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Kombinationskemoterapi med eller uden Blinatumomab til behandling af patienter med nyligt diagnosticeret BCR-ABL-negativ B-linje Akut lymfoblastisk leukæmi

11. november 2026 opdateret af: National Cancer Institute (NCI)

Et fase III randomiseret forsøg med Blinatumomab for nyligt diagnosticeret BCR-ABL-negativ B-linje Akut lymfoblastisk leukæmi hos voksne

This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Aktiv, ikke rekrutterende

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

PRIMARY OBJECTIVE:

I. To compare the overall survival (OS) of blinatumomab in conjunction with chemotherapy to chemotherapy alone in patients with BCR-ABL-negative B cell precursor acute lymphoblastic leukemia (ALL) who are minimal residual disease (MRD) negative after induction and intensification chemotherapy, based on multiparameter flow cytometric (MFC) assessment of residual blasts.

SECONDARY OBJECTIVES:

I. To compare the relapse-free survival (RFS) of blinatumomab in conjunction with chemotherapy to chemotherapy alone in MRD negative patients after induction and intensification chemotherapy.

II. To compare the OS and RFS of those patients who are MRD positive (+) at step 3 randomization/registration and then convert to MRD negative (-) after 2 cycles of blinatumomab to those patients who are MRD- at randomization and remain MRD- after 2 cycles of blinatumomab or consolidation chemotherapy.

III. To assess the toxicities of blinatumomab in this patient population. IV. To assess the toxicities of the modified E2993 chemotherapy regimen in this patient population.

V. To describe the outcome of patients who proceed to allogeneic blood or marrow transplant after treatment with or without blinatumomab.

LABORATORY OBJECTIVES:

I. To determine differences in MRD kinetics among patients with the BCR/ABL1-like B-lineage ALL, and to compare the OS (and RFS) of patients with BCR-ABL-like phenotype with those without BCR-ABL-like phenotype.

II. To evaluate the incidence of anti-blinatumomab antibody formation.

OUTLINE:

INDUCTION CHEMOTHERAPY: Patients receive cytarabine intrathecally (IT) on day 1; daunorubicin hydrochloride intravenously (IV) over 10-15 minutes on days 1, 8, 15, and 22; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally (PO) daily on days 1-7 (and 15-21 for patients age < 55 years only); methotrexate IT on day 14; pegaspargase intramuscularly (IM) or IV on day 18 (patients age < 55 years); and CD20 positive patients may optionally receive rituximab IV on day 8 and 15. Beginning on day 29, patients with absolute neutrophil count (ANC) >= 0.75 x 10^9/L and platelets > 75 x 10^9/L (patients with delayed hematologic recovery) (patients with residual disease that is delaying count begin treatment immediately) receive cyclophosphamide IV over 30 minutes on days 1 and 29, cytarabine IV over 30 minutes or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO on days 1-14, 29-42, pegaspargase IM or IV on day 15 (patients age < 55 years), patients receiving treatment for central nervous system (CNS) 2 or 3 leukemia in cycle 1 receive methotrexate IT on days 1, 8, 15, and 22, and CD20 positive patients may optionally receive rituximab IV on days 8 and 15.

INTENSIFICATION THERAPY: Beginning 4 weeks after the completion of cycle 2 of induction therapy, patients receive intensification therapy comprising high-dose methotrexate IV over 2 hours on days 1 and 8, and pegaspargase IM or IV on day 9.

Patients are then randomized to 1 of 2 treatment arms.

Patients randomized to the blinatumomab group receive blinatumomab IV continuously on days 1-28. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients may then undergo allogeneic stem cell transplant (SCT) or proceed to consolidation therapy per investigator discretion.

CONSOLIDATION THERAPY: Beginning after the second cycle of blinatumomab (patients randomized to the blinatumomab group) or after intensification therapy (patients not randomized to blinatumomab), patients receive cytarabine IV over 30 minutes or SC on days 1-5, etoposide IV over 1 hour on days 1-5, methotrexate IT on day 1, and pegaspargase IM or IV on day 5, and CD20 positive patients may optionally receive rituximab IV on day 5. Beginning 4 weeks from day 1 of cycle 1, patients receive cytarabine, etoposide, methotrexate, and CD20 positive patients may receive rituximab as in cycle 1. Beginning 4 weeks from day 1 of cycle 2, patients receive daunorubicin hydrochloride IV over 10-15 minutes on day 1, 8, 15, and 22; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone PO daily on days 1-7 (and 15-21 for patients age < 55 years); methotrexate IT on day 2; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV over 30 minutes or SC on days 30-33 and 37-40; mercaptopurine PO on days 29-42 and CD20 positive patients may receive rituximab on day 8. Beginning 8 weeks from day 1 of cycle 3, patients receive cytarabine, etoposide, methotrexate, and CD20 positive patients may optionally receive rituximab as in cycle 1. Patients randomized to blinatumomab repeat cycle 4 and then receive blinatumomab IV continuously on days 1-28.

MAINTENANCE THERAPY: Within 6 weeks after beginning last cycle of consolidation therapy, patients receive mercaptopurine PO daily, methotrexate PO or IV over 2 hours once weekly for 2.5 years, vincristine sulfate IV on day 1 every 3 months, prednisone PO on days 1-5 every 3 months, and methotrexate IT on day 1 every 3 months. Treatment continues for up to 2.5 years in the absence of disease progression or unacceptable toxicity.

Patients undergo x-ray imaging during screening, lumbar puncture while on study, and bone marrow aspiration, bone marrow biopsy, and blood sample collection throughout the study.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every 12 months for 5 years.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Faktiske)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
488

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Arthur J E Child Comprehensive Cancer Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3P1
        • Clinical Research Unit at Vancouver Coastal Health Authority
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QEII Health Sciences Centre/Nova Scotia Health Authority
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSSEMTL-Hopital Maisonneuve-Rosemont
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • University of Alabama at Birmingham Cancer Center
    • Alaska
      • Anchorage, Alaska, Forenede Stater, 98508
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, Forenede Stater, 99508
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, Forenede Stater, 99508
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, Forenede Stater, 99508
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, Forenede Stater, 99508
        • Anchorage Oncology Centre
      • Anchorage, Alaska, Forenede Stater, 99508
        • Katmai Oncology Group
      • Anchorage, Alaska, Forenede Stater, 99508
        • Providence Alaska Medical Center
      • Anchorage, Alaska, Forenede Stater, 99504
        • Anchorage Radiation Therapy Center
      • Anchorage, Alaska, Forenede Stater, 99508
        • Alaska Regional Hospital
      • Fairbanks, Alaska, Forenede Stater, 99701
        • Fairbanks Memorial Hospital
    • Arizona
      • Kingman, Arizona, Forenede Stater, 86401
        • Kingman Regional Medical Center
      • Tucson, Arizona, Forenede Stater, 85719
        • Banner University Medical Center - Tucson
      • Tucson, Arizona, Forenede Stater, 85719
        • University of Arizona Cancer Center-North Campus
    • Arkansas
      • Fort Smith, Arkansas, Forenede Stater, 72903
        • Mercy Hospital Fort Smith
      • Little Rock, Arkansas, Forenede Stater, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Arroyo Grande, California, Forenede Stater, 93420
        • PCR Oncology
      • Burbank, California, Forenede Stater, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Clovis, California, Forenede Stater, 93611
        • Community Cancer Institute
      • Clovis, California, Forenede Stater, 93611
        • University Oncology Associates
      • La Jolla, California, Forenede Stater, 92093
        • UC San Diego Moores Cancer Center
      • Orange, California, Forenede Stater, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Palo Alto, California, Forenede Stater, 94304
        • Stanford Cancer Institute Palo Alto
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80012
        • Rocky Mountain Cancer Centers-Aurora
      • Aurora, Colorado, Forenede Stater, 80012
        • The Medical Center of Aurora
      • Boulder, Colorado, Forenede Stater, 80303
        • Boulder Community Foothills Hospital
      • Boulder, Colorado, Forenede Stater, 80304
        • Rocky Mountain Cancer Centers-Boulder
      • Denver, Colorado, Forenede Stater, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, Forenede Stater, 80220
        • Rose Medical Center
      • Denver, Colorado, Forenede Stater, 80218
        • Rocky Mountain Cancer Centers-Midtown
      • Denver, Colorado, Forenede Stater, 80220
        • Rocky Mountain Cancer Centers-Rose
      • Denver, Colorado, Forenede Stater, 80218
        • Colorado Blood Cancer Institute
      • Denver, Colorado, Forenede Stater, 80204
        • Cancer Center of Colorado at Sloan's Lake
      • Denver, Colorado, Forenede Stater, 80209
        • The Women's Imaging Center
      • Denver, Colorado, Forenede Stater, 80206
        • National Jewish Health-Main Campus
      • Denver, Colorado, Forenede Stater, 80220
        • Western Surgical Care
      • Denver, Colorado, Forenede Stater, 80218
        • Saint Joseph Hospital - Cancer Centers of Colorado
      • Englewood, Colorado, Forenede Stater, 80113
        • Mountain Blue Cancer Care Center - Swedish
      • Englewood, Colorado, Forenede Stater, 80113
        • Swedish Medical Center
      • Golden, Colorado, Forenede Stater, 80401
        • National Jewish Health-Western Hematology Oncology
      • Grand Junction, Colorado, Forenede Stater, 81501
        • Saint Mary's Hospital and Regional Medical Center
      • Grand Junction, Colorado, Forenede Stater, 81505
        • Grand Valley Oncology
      • Greeley, Colorado, Forenede Stater, 80631
        • Banner North Colorado Medical Center
      • Lafayette, Colorado, Forenede Stater, 80026
        • Good Samaritan Hospital - Cancer Centers of Colorado
      • Littleton, Colorado, Forenede Stater, 80120
        • Rocky Mountain Cancer Centers-Littleton
      • Lone Tree, Colorado, Forenede Stater, 80124
        • Sky Ridge Medical Center
      • Lone Tree, Colorado, Forenede Stater, 80124
        • Rocky Mountain Cancer Centers-Sky Ridge
      • Loveland, Colorado, Forenede Stater, 80539
        • Banner North Colorado Medical Center - Loveland Campus
      • Thornton, Colorado, Forenede Stater, 80260
        • National Jewish Health-Northern Hematology Oncology
      • Wheat Ridge, Colorado, Forenede Stater, 80401
        • Intermountain Health Lutheran Hospital
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06105
        • Smilow Cancer Hospital Care Center at Saint Francis
      • New Haven, Connecticut, Forenede Stater, 06520
        • Yale University
      • Torrington, Connecticut, Forenede Stater, 06790
        • Smilow Cancer Hospital-Torrington Care Center
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20016
        • Sibley Memorial Hospital
    • Florida
      • Coral Springs, Florida, Forenede Stater, 33065
        • UM Sylvester Comprehensive Cancer Center at Coral Springs
      • Deerfield Beach, Florida, Forenede Stater, 33442
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
      • Hollywood, Florida, Forenede Stater, 33021
        • UM Sylvester Comprehensive Cancer Center at Hollywood
      • Jacksonville, Florida, Forenede Stater, 32207
        • Baptist MD Anderson Cancer Center
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Miami, Florida, Forenede Stater, 33176
        • UM Sylvester Comprehensive Cancer Center at Kendall
      • Plantation, Florida, Forenede Stater, 33324
        • UM Sylvester Comprehensive Cancer Center at Plantation
      • Weston, Florida, Forenede Stater, 33331
        • Cleveland Clinic-Weston
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Atlanta, Georgia, Forenede Stater, 30342
        • Northside Hospital
    • Idaho
      • Boise, Idaho, Forenede Stater, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Boise, Idaho, Forenede Stater, 83712
        • Saint Luke's Cancer Institute - Boise
      • Caldwell, Idaho, Forenede Stater, 83605
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene, Idaho, Forenede Stater, 83814
        • Kootenai Health - Coeur d'Alene
      • Emmett, Idaho, Forenede Stater, 83617
        • Walter Knox Memorial Hospital
      • Fruitland, Idaho, Forenede Stater, 83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, Forenede Stater, 83642
        • Idaho Urologic Institute-Meridian
      • Meridian, Idaho, Forenede Stater, 83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, Forenede Stater, 83687
        • Saint Alphonsus Cancer Care Center-Nampa
      • Nampa, Idaho, Forenede Stater, 83687
        • Saint Luke's Cancer Institute - Nampa
      • Post Falls, Idaho, Forenede Stater, 83854
        • Kootenai Clinic Cancer Services - Post Falls
      • Sandpoint, Idaho, Forenede Stater, 83864
        • Kootenai Clinic Cancer Services - Sandpoint
      • Twin Falls, Idaho, Forenede Stater, 83301
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Bloomington, Illinois, Forenede Stater, 61704
        • Illinois CancerCare-Bloomington
      • Bloomington, Illinois, Forenede Stater, 61701
        • OSF Saint Joseph Medical Center
      • Canton, Illinois, Forenede Stater, 61520
        • Illinois CancerCare-Canton
      • Carbondale, Illinois, Forenede Stater, 62902
        • Memorial Hospital of Carbondale
      • Carterville, Illinois, Forenede Stater, 62918
        • SIH Cancer Institute
      • Carthage, Illinois, Forenede Stater, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, Forenede Stater, 62801
        • Centralia Oncology Clinic
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Illinois
      • Chicago, Illinois, Forenede Stater, 60608
        • Mount Sinai Hospital Medical Center
      • Decatur, Illinois, Forenede Stater, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, Forenede Stater, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Dixon, Illinois, Forenede Stater, 61021
        • Illinois CancerCare-Dixon
      • Effingham, Illinois, Forenede Stater, 62401
        • Crossroads Cancer Center
      • Eureka, Illinois, Forenede Stater, 61530
        • Illinois CancerCare-Eureka
      • Evanston, Illinois, Forenede Stater, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Galesburg, Illinois, Forenede Stater, 61401
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, Forenede Stater, 61401
        • Illinois CancerCare-Galesburg
      • Glenview, Illinois, Forenede Stater, 60026
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Highland Park, Illinois, Forenede Stater, 60035
        • NorthShore University HealthSystem-Highland Park Hospital
      • Highland Park, Illinois, Forenede Stater, 60035
        • Hematology Oncology Associates of Illinois-Highland Park
      • Kankakee, Illinois, Forenede Stater, 60901
        • Presence Saint Mary's Hospital
      • Kewanee, Illinois, Forenede Stater, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Libertyville, Illinois, Forenede Stater, 60048
        • AMG Libertyville - Oncology
      • Macomb, Illinois, Forenede Stater, 61455
        • Illinois CancerCare-Macomb
      • Maywood, Illinois, Forenede Stater, 60153
        • Loyola University Medical Center
      • Mount Vernon, Illinois, Forenede Stater, 62864
        • SSM Health Good Samaritan
      • Niles, Illinois, Forenede Stater, 60714
        • Illinois Cancer Specialists-Niles
      • O'Fallon, Illinois, Forenede Stater, 62269
        • Cancer Care Center of O'Fallon
      • Ottawa, Illinois, Forenede Stater, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Ottawa, Illinois, Forenede Stater, 61350
        • Radiation Oncology of Northern Illinois
      • Pekin, Illinois, Forenede Stater, 61554
        • Illinois CancerCare-Pekin
      • Pekin, Illinois, Forenede Stater, 61554
        • OSF Saint Francis Radiation Oncology at Pekin
      • Peoria, Illinois, Forenede Stater, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Forenede Stater, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, Forenede Stater, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, Forenede Stater, 61615
        • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
      • Peru, Illinois, Forenede Stater, 61354
        • Illinois CancerCare-Peru
      • Peru, Illinois, Forenede Stater, 61354
        • Valley Radiation Oncology
      • Princeton, Illinois, Forenede Stater, 61356
        • Illinois CancerCare-Princeton
      • Skokie, Illinois, Forenede Stater, 60076
        • Hematology Oncology Associates of Illinois - Skokie
      • Skokie, Illinois, Forenede Stater, 60076
        • North Shore Medical Center
      • Springfield, Illinois, Forenede Stater, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, Forenede Stater, 62702
        • Springfield Clinic
      • Springfield, Illinois, Forenede Stater, 62702
        • Central Illinois Hematology Oncology Center
      • Springfield, Illinois, Forenede Stater, 62781
        • Springfield Memorial Hospital
      • Swansea, Illinois, Forenede Stater, 62226
        • Southwest Illinois Health Services LLP
    • Indiana
      • Fort Wayne, Indiana, Forenede Stater, 46805
        • Parkview Hospital Randallia
      • Fort Wayne, Indiana, Forenede Stater, 46845
        • Parkview Regional Medical Center
      • Indianapolis, Indiana, Forenede Stater, 46237
        • Franciscan Health Indianapolis
      • Mooresville, Indiana, Forenede Stater, 46158
        • Franciscan Health Mooresville
      • Richmond, Indiana, Forenede Stater, 47374
        • Reid Health
    • Iowa
      • Ames, Iowa, Forenede Stater, 50010
        • Mary Greeley Medical Center
      • Ames, Iowa, Forenede Stater, 50010
        • McFarland Clinic - Ames
      • Boone, Iowa, Forenede Stater, 50036
        • McFarland Clinic - Boone
      • Fort Dodge, Iowa, Forenede Stater, 50501
        • McFarland Clinic - Trinity Cancer Center
      • Jefferson, Iowa, Forenede Stater, 50129
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, Forenede Stater, 50158
        • McFarland Clinic - Marshalltown
    • Kansas
      • Chanute, Kansas, Forenede Stater, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, Forenede Stater, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, Forenede Stater, 67042
        • Cancer Center of Kansas - El Dorado
      • Fort Scott, Kansas, Forenede Stater, 66701
        • Cancer Center of Kansas - Fort Scott
      • Garden City, Kansas, Forenede Stater, 67846
        • Central Care Cancer Center - Garden City
      • Great Bend, Kansas, Forenede Stater, 67530
        • Central Care Cancer Center - Great Bend
      • Independence, Kansas, Forenede Stater, 67301
        • Cancer Center of Kansas-Independence
      • Kansas City, Kansas, Forenede Stater, 66160
        • University of Kansas Cancer Center
      • Kingman, Kansas, Forenede Stater, 67068
        • Cancer Center of Kansas-Kingman
      • Lawrence, Kansas, Forenede Stater, 66044
        • Lawrence Memorial Hospital
      • Lenexa, Kansas, Forenede Stater, 66219
        • Kansas Institute of Medicine Cancer and Blood Center
      • Lenexa, Kansas, Forenede Stater, 66219
        • Minimally Invasive Surgery Hospital
      • Liberal, Kansas, Forenede Stater, 67905
        • Cancer Center of Kansas-Liberal
      • Manhattan, Kansas, Forenede Stater, 66502
        • Cancer Center of Kansas-Manhattan
      • McPherson, Kansas, Forenede Stater, 67460
        • Cancer Center of Kansas - McPherson
      • Newton, Kansas, Forenede Stater, 67114
        • Cancer Center of Kansas - Newton
      • Olathe, Kansas, Forenede Stater, 66061
        • The University of Kansas Cancer Center - Olathe
      • Overland Park, Kansas, Forenede Stater, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, Forenede Stater, 66213
        • Saint Luke's South Hospital
      • Parsons, Kansas, Forenede Stater, 67357
        • Cancer Center of Kansas - Parsons
      • Pratt, Kansas, Forenede Stater, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, Forenede Stater, 67401
        • Cancer Center of Kansas - Salina
      • Wellington, Kansas, Forenede Stater, 67152
        • Cancer Center of Kansas - Wellington
      • Westwood, Kansas, Forenede Stater, 66205
        • University of Kansas Hospital-Westwood Cancer Center
      • Wichita, Kansas, Forenede Stater, 67214
        • Ascension Via Christi Hospitals Wichita
      • Wichita, Kansas, Forenede Stater, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, Forenede Stater, 67214
        • Cancer Center of Kansas - Wichita
      • Wichita, Kansas, Forenede Stater, 67208
        • Associates In Womens Health
      • Wichita, Kansas, Forenede Stater, 67214
        • Wesley Medical Center
      • Winfield, Kansas, Forenede Stater, 67156
        • Cancer Center of Kansas - Winfield
    • Kentucky
      • Crestview Hills, Kentucky, Forenede Stater, 41017
        • Oncology Hematology Care Inc-Crestview
      • Louisville, Kentucky, Forenede Stater, 40202
        • The James Graham Brown Cancer Center at University of Louisville
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70809
        • Ochsner Health Center-Summa
      • Baton Rouge, Louisiana, Forenede Stater, 70816
        • Medical Center of Baton Rouge
      • Baton Rouge, Louisiana, Forenede Stater, 70836
        • Ochsner High Grove
      • Monroe, Louisiana, Forenede Stater, 71202
        • Ochsner LSU Health Monroe Medical Center
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Medical Center Jefferson
      • Shreveport, Louisiana, Forenede Stater, 71103
        • LSU Health Sciences Center at Shreveport
    • Maine
      • Bangor, Maine, Forenede Stater, 04401
        • Eastern Maine Medical Center
      • Brewer, Maine, Forenede Stater, 04412
        • Lafayette Family Cancer Center-EMMC
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
      • Baltimore, Maryland, Forenede Stater, 21201
        • University of Maryland/Greenebaum Cancer Center
      • Bethesda, Maryland, Forenede Stater, 20889-5600
        • Walter Reed National Military Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Forenede Stater, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital Cancer Center
    • Michigan
      • Adrian, Michigan, Forenede Stater, 49221
        • Bixby Medical Center
      • Adrian, Michigan, Forenede Stater, 49221
        • Hickman Cancer Center
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Battle Creek, Michigan, Forenede Stater, 49017
        • Bronson Battle Creek
      • Brownstown, Michigan, Forenede Stater, 48183
        • Henry Ford Cancer Institute-Downriver
      • Clinton Township, Michigan, Forenede Stater, 48038
        • Henry Ford Macomb Hospital-Clinton Township
      • Dearborn, Michigan, Forenede Stater, 48126
        • Henry Ford Medical Center-Fairlane
      • Dearborn, Michigan, Forenede Stater, 48124
        • Corewell Health Dearborn Hospital
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, Forenede Stater, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Detroit, Michigan, Forenede Stater, 48236
        • Henry Ford Health Saint John Hospital
      • Escanaba, Michigan, Forenede Stater, 49829
        • OSF Saint Francis Hospital and Medical Group
      • Farmington Hills, Michigan, Forenede Stater, 48334
        • Weisberg Cancer Treatment Center
      • Farmington Hills, Michigan, Forenede Stater, 48336
        • Corewell Health Farmington Hills Hospital
      • Flint, Michigan, Forenede Stater, 48503
        • Hurley Medical Center
      • Flint, Michigan, Forenede Stater, 48503
        • Genesys Hurley Cancer Institute
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Trinity Health Grand Rapids Hospital
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
      • Grosse Pointe, Michigan, Forenede Stater, 48230
        • William Beaumont Hospital-Grosse Pointe
      • Jackson, Michigan, Forenede Stater, 49201
        • Allegiance Health
      • Kalamazoo, Michigan, Forenede Stater, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, Forenede Stater, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Forenede Stater, 49048
        • Beacon Kalamazoo
      • Lansing, Michigan, Forenede Stater, 48912
        • University of Michigan Health - Sparrow Lansing
      • Livonia, Michigan, Forenede Stater, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Monroe, Michigan, Forenede Stater, 48162
        • Mercy Memorial Hospital
      • Monroe, Michigan, Forenede Stater, 48162
        • Toledo Clinic Cancer Centers-Monroe
      • Muskegon, Michigan, Forenede Stater, 49444
        • Trinity Health Muskegon Hospital
      • Niles, Michigan, Forenede Stater, 49120
        • Corewell Health Lakeland Hospitals - Niles Hospital
      • Norton Shores, Michigan, Forenede Stater, 49444
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
      • Novi, Michigan, Forenede Stater, 48377
        • Henry Ford Medical Center-Columbus
      • Pontiac, Michigan, Forenede Stater, 48341
        • Trinity Health Saint Joseph Mercy Oakland Hospital
      • Port Huron, Michigan, Forenede Stater, 48060
        • Lake Huron Medical Center
      • Port Huron, Michigan, Forenede Stater, 48060
        • Huron Medical Center PC
      • Reed City, Michigan, Forenede Stater, 49677
        • Corewell Health Reed City Hospital
      • Roseville, Michigan, Forenede Stater, 48066
        • Michigan Cancer Specialists
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Cancer Care Associates PC
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Comprehensive Medical Center PLLC
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Oakland Medical Group
      • Royal Oak, Michigan, Forenede Stater, 48067
        • Oakland Colon Rectal Associates
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Hematology Oncology Consultants PC-Royal Oak
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Corewell Health William Beaumont University Hospital
      • Saginaw, Michigan, Forenede Stater, 48601
        • MyMichigan Medical Center Saginaw
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
      • Sterling Heights, Michigan, Forenede Stater, 48312
        • Premier Hematology Oncology Care
      • Sterling Heights, Michigan, Forenede Stater, 48314
        • Mitchell Folbe MD PC
      • Traverse City, Michigan, Forenede Stater, 49684
        • Munson Medical Center
      • Troy, Michigan, Forenede Stater, 48084
        • Michigan Institute of Urology-Town Center
      • Troy, Michigan, Forenede Stater, 48085
        • Claudia BR Herke MD PC
      • Troy, Michigan, Forenede Stater, 48098
        • Hematology Oncology Consultants PC-Troy
      • Troy, Michigan, Forenede Stater, 48085
        • Corewell Health Beaumont Troy Hospital
      • Warren, Michigan, Forenede Stater, 48093
        • Henry Ford Health Warren Hospital
      • West Bloomfield, Michigan, Forenede Stater, 48322
        • Henry Ford West Bloomfield Hospital
      • Wyoming, Michigan, Forenede Stater, 49519
        • University of Michigan Health - West
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic in Rochester
    • Missouri
      • Ballwin, Missouri, Forenede Stater, 63011
        • Mercy Oncology and Hematology - Clayton-Clarkson
      • Bolivar, Missouri, Forenede Stater, 65613
        • Central Care Cancer Center - Bolivar
      • Bonne Terre, Missouri, Forenede Stater, 63628
        • Parkland Health Center-Bonne Terre
      • Branson, Missouri, Forenede Stater, 65616
        • Cox Cancer Center Branson
      • Cape Girardeau, Missouri, Forenede Stater, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, Forenede Stater, 63703
        • Mercy Cancer Center - Cape Girardeau
      • City of Saint Peters, Missouri, Forenede Stater, 63376
        • Siteman Cancer Center at Saint Peters Hospital
      • Creve Coeur, Missouri, Forenede Stater, 63141
        • Siteman Cancer Center at West County Hospital
      • Farmington, Missouri, Forenede Stater, 63640
        • Parkland Health Center - Farmington
      • Independence, Missouri, Forenede Stater, 64057
        • Centerpoint Medical Center LLC
      • Jefferson City, Missouri, Forenede Stater, 65109
        • MU Health Care Goldschmidt Cancer Center
      • Joplin, Missouri, Forenede Stater, 64804
        • Freeman Health System
      • Joplin, Missouri, Forenede Stater, 64804
        • Mercy Hospital Joplin
      • Kansas City, Missouri, Forenede Stater, 64111
        • Saint Luke's Hospital of Kansas City
      • Kansas City, Missouri, Forenede Stater, 64132
        • Research Medical Center
      • Kansas City, Missouri, Forenede Stater, 64118
        • Heartland Hematology and Oncology Associates Incorporated
      • Lee's Summit, Missouri, Forenede Stater, 64086
        • Saint Luke's East - Lee's Summit
      • Liberty, Missouri, Forenede Stater, 64068
        • Liberty Hospital
      • Rolla, Missouri, Forenede Stater, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, Forenede Stater, 65401
        • Phelps Health Delbert Day Cancer Institute
      • Saint Joseph, Missouri, Forenede Stater, 64506
        • Heartland Regional Medical Center
      • Sainte Genevieve, Missouri, Forenede Stater, 63670
        • Sainte Genevieve County Memorial Hospital
      • Springfield, Missouri, Forenede Stater, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Forenede Stater, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, Forenede Stater, 63129
        • Siteman Cancer Center-South County
      • St Louis, Missouri, Forenede Stater, 63131
        • Missouri Baptist Medical Center
      • St Louis, Missouri, Forenede Stater, 63109
        • Mercy Infusion Center - Chippewa
      • St Louis, Missouri, Forenede Stater, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, Forenede Stater, 63128
        • Mercy Hospital South
      • Sullivan, Missouri, Forenede Stater, 63080
        • Missouri Baptist Sullivan Hospital
      • Washington, Missouri, Forenede Stater, 63090
        • Mercy Hospital Washington
    • Montana
      • Anaconda, Montana, Forenede Stater, 59711
        • Community Hospital of Anaconda
      • Billings, Montana, Forenede Stater, 59101
        • Billings Clinic Cancer Center
      • Billings, Montana, Forenede Stater, 59101
        • Saint Vincent Healthcare
      • Billings, Montana, Forenede Stater, 59102
        • Saint Vincent Frontier Cancer Center
      • Bozeman, Montana, Forenede Stater, 59715
        • Bozeman Health Deaconess Hospital
      • Butte, Montana, Forenede Stater, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, Forenede Stater, 59405
        • Great Falls Clinic
      • Great Falls, Montana, Forenede Stater, 59405
        • Benefis Sletten Cancer Institute
      • Helena, Montana, Forenede Stater, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, Forenede Stater, 59901
        • Logan Health Medical Center
      • Missoula, Montana, Forenede Stater, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, Forenede Stater, 59804
        • Community Medical Center
    • Nebraska
      • Bellevue, Nebraska, Forenede Stater, 68123
        • Nebraska Medicine-Bellevue
      • Omaha, Nebraska, Forenede Stater, 68198
        • University of Nebraska Medical Center
      • Omaha, Nebraska, Forenede Stater, 68118
        • Nebraska Medicine-Village Pointe
    • Nevada
      • Carson City, Nevada, Forenede Stater, 89703
        • Carson Tahoe Regional Medical Center
      • Henderson, Nevada, Forenede Stater, 89052
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson, Nevada, Forenede Stater, 89052
        • Cancer and Blood Specialists-Henderson
      • Henderson, Nevada, Forenede Stater, 89052
        • Las Vegas Cancer Center-Henderson
      • Henderson, Nevada, Forenede Stater, 89074
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
      • Henderson, Nevada, Forenede Stater, 89052
        • Comprehensive Cancer Centers of Nevada-Horizon Ridge
      • Henderson, Nevada, Forenede Stater, 89074
        • Las Vegas Urology - Green Valley
      • Henderson, Nevada, Forenede Stater, 89074
        • Las Vegas Urology - Pebble
      • Henderson, Nevada, Forenede Stater, 89074
        • Urology Specialists of Nevada - Green Valley
      • Henderson, Nevada, Forenede Stater, 89074
        • Oncology Las Vegas - Henderson
      • Las Vegas, Nevada, Forenede Stater, 89144
        • Summerlin Hospital Medical Center
      • Las Vegas, Nevada, Forenede Stater, 89109
        • Sunrise Hospital and Medical Center
      • Las Vegas, Nevada, Forenede Stater, 89102
        • OptumCare Cancer Care at Charleston
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Radiation Oncology Centers of Nevada Central
      • Las Vegas, Nevada, Forenede Stater, 89119
        • Radiation Oncology Centers of Nevada Southeast
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Comprehensive Cancer Centers of Nevada - Northwest
      • Las Vegas, Nevada, Forenede Stater, 89128
        • OptumCare Cancer Care at MountainView
      • Las Vegas, Nevada, Forenede Stater, 89135
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
      • Las Vegas, Nevada, Forenede Stater, 89144
        • Comprehensive Cancer Centers of Nevada - Town Center
      • Las Vegas, Nevada, Forenede Stater, 89144
        • Comprehensive Cancer Centers of Nevada-Summerlin
      • Las Vegas, Nevada, Forenede Stater, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Forenede Stater, 89169
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, Forenede Stater, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Cancer and Blood Specialists-Shadow
      • Las Vegas, Nevada, Forenede Stater, 89109
        • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
      • Las Vegas, Nevada, Forenede Stater, 89113
        • HealthCare Partners Medical Group Oncology/Hematology-San Martin
      • Las Vegas, Nevada, Forenede Stater, 89121
        • Cancer Therapy and Integrative Medicine
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Cancer and Blood Specialists-Tenaya
      • Las Vegas, Nevada, Forenede Stater, 89128
        • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
      • Las Vegas, Nevada, Forenede Stater, 89148-2405
        • Las Vegas Cancer Center-Medical Center
      • Las Vegas, Nevada, Forenede Stater, 89149
        • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Ann M Wierman MD LTD
      • Las Vegas, Nevada, Forenede Stater, 89074
        • Las Vegas Urology - Pecos
      • Las Vegas, Nevada, Forenede Stater, 89102
        • Desert West Surgery
      • Las Vegas, Nevada, Forenede Stater, 89103
        • Hope Cancer Care of Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Urology Specialists of Nevada - Central
      • Las Vegas, Nevada, Forenede Stater, 89113
        • Las Vegas Prostate Cancer Center
      • Las Vegas, Nevada, Forenede Stater, 89113
        • Las Vegas Urology - Sunset
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Las Vegas Urology - Cathedral Rock
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Las Vegas Urology - Smoke Ranch
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Urology Specialists of Nevada - Northwest
      • Las Vegas, Nevada, Forenede Stater, 89169
        • University Cancer Center
      • Las Vegas, Nevada, Forenede Stater, 89113
        • Urology Specialists of Nevada - Southwest
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Oncology Las Vegas - Tenaya
      • Las Vegas, Nevada, Forenede Stater, 89183
        • OptumCare Cancer Care at Fort Apache
      • Pahrump, Nevada, Forenede Stater, 89048
        • Hope Cancer Care of Nevada-Pahrump
      • Reno, Nevada, Forenede Stater, 89502
        • Renown Regional Medical Center
      • Reno, Nevada, Forenede Stater, 89503
        • Saint Mary's Regional Medical Center
      • Reno, Nevada, Forenede Stater, 89509
        • Radiation Oncology Associates
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
    • New Jersey
      • Basking Ridge, New Jersey, Forenede Stater, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Middletown, New Jersey, Forenede Stater, 07748
        • Memorial Sloan Kettering Monmouth
      • Montvale, New Jersey, Forenede Stater, 07645
        • Memorial Sloan Kettering Bergen
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • Rutgers Cancer Institute of New Jersey
    • New York
      • Buffalo, New York, Forenede Stater, 14263
        • Roswell Park Cancer Institute
      • Commack, New York, Forenede Stater, 11725
        • Memorial Sloan Kettering Commack
      • Harrison, New York, Forenede Stater, 10604
        • Memorial Sloan Kettering Westchester
      • Lake Success, New York, Forenede Stater, 11042
        • Northwell Health/Center for Advanced Medicine
      • Manhasset, New York, Forenede Stater, 11030
        • North Shore University Hospital
      • New Hyde Park, New York, Forenede Stater, 11040
        • Long Island Jewish Medical Center
      • New York, New York, Forenede Stater, 10065
        • Memorial Sloan Kettering Cancer Center
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester
      • Stony Brook, New York, Forenede Stater, 11794
        • Stony Brook University Medical Center
      • The Bronx, New York, Forenede Stater, 10461
        • Montefiore Medical Center-Einstein Campus
      • The Bronx, New York, Forenede Stater, 10467
        • Montefiore Medical Center - Moses Campus
      • The Bronx, New York, Forenede Stater, 10461
        • Montefiore Medical Center-Weiler Hospital
      • Uniondale, New York, Forenede Stater, 11553
        • Memorial Sloan Kettering Nassau
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28803
        • AdventHealth Infusion Center Asheville
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Clyde, North Carolina, Forenede Stater, 28721
        • AdventHealth Infusion Center Haywood
      • Hendersonville, North Carolina, Forenede Stater, 28792
        • AdventHealth Hendersonville
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Beavercreek, Ohio, Forenede Stater, 45431
        • Indu and Raj Soin Medical Center
      • Boardman, Ohio, Forenede Stater, 44512
        • Saint Elizabeth Boardman Hospital
      • Bowling Green, Ohio, Forenede Stater, 43402
        • Toledo Clinic Cancer Centers-Bowling Green
      • Centerville, Ohio, Forenede Stater, 45459
        • Miami Valley Hospital South
      • Centerville, Ohio, Forenede Stater, 45459
        • Dayton Physicians LLC-Miami Valley South
      • Cincinnati, Ohio, Forenede Stater, 45219
        • University of Cincinnati Cancer Center-UC Medical Center
      • Cincinnati, Ohio, Forenede Stater, 45242
        • Oncology Hematology Care Inc-Blue Ash
      • Cincinnati, Ohio, Forenede Stater, 45202
        • Oncology Hematology Care Inc-Eden Park
      • Cincinnati, Ohio, Forenede Stater, 45211
        • Oncology Hematology Care Inc-Mercy West
      • Cincinnati, Ohio, Forenede Stater, 45230
        • Oncology Hematology Care Inc-Anderson
      • Cincinnati, Ohio, Forenede Stater, 45236
        • Oncology Hematology Care Inc-Kenwood
      • Cleveland, Ohio, Forenede Stater, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, Forenede Stater, 43210
        • Ohio State University Comprehensive Cancer Center
      • Dayton, Ohio, Forenede Stater, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, Forenede Stater, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, Forenede Stater, 45415
        • Miami Valley Hospital North
      • Dayton, Ohio, Forenede Stater, 45415
        • Dayton Physician LLC - Englewood
      • Fairfield, Ohio, Forenede Stater, 45014
        • Oncology Hematology Care Inc-Healthplex
      • Findlay, Ohio, Forenede Stater, 45840
        • Blanchard Valley Hospital
      • Findlay, Ohio, Forenede Stater, 45840
        • Armes Family Cancer Center
      • Findlay, Ohio, Forenede Stater, 45840
        • Orion Cancer Care
      • Franklin, Ohio, Forenede Stater, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Franklin, Ohio, Forenede Stater, 45005
        • Dayton Physicians LLC-Atrium
      • Greenville, Ohio, Forenede Stater, 45331
        • Wayne Hospital
      • Greenville, Ohio, Forenede Stater, 45331
        • Dayton Physicians LLC-Wayne
      • Kettering, Ohio, Forenede Stater, 45429
        • Kettering Medical Center
      • Kettering, Ohio, Forenede Stater, 45409
        • Greater Dayton Cancer Center
      • Kettering, Ohio, Forenede Stater, 45420
        • First Dayton Cancer Care
      • Lima, Ohio, Forenede Stater, 45804
        • Lima Memorial Hospital
      • Maumee, Ohio, Forenede Stater, 43537
        • Toledo Clinic Cancer Centers-Maumee
      • Maumee, Ohio, Forenede Stater, 43537
        • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
      • Middletown, Ohio, Forenede Stater, 45042
        • Dayton Physicians LLC-Signal Point
      • Oregon, Ohio, Forenede Stater, 43616
        • Saint Charles Hospital
      • Oregon, Ohio, Forenede Stater, 43616
        • Toledo Clinic Cancer Centers-Oregon
      • Sidney, Ohio, Forenede Stater, 45365
        • Dayton Physicians LLC-Wilson
      • Springfield, Ohio, Forenede Stater, 45504
        • Springfield Regional Cancer Center
      • Springfield, Ohio, Forenede Stater, 45504
        • Springfield Regional Medical Center
      • Sylvania, Ohio, Forenede Stater, 43560
        • ProMedica Flower Hospital
      • Tiffin, Ohio, Forenede Stater, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, Forenede Stater, 43606
        • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
      • Toledo, Ohio, Forenede Stater, 43623
        • Mercy Health - Saint Anne Hospital
      • Toledo, Ohio, Forenede Stater, 43623
        • Toledo Clinic Cancer Centers-Toledo
      • Toledo, Ohio, Forenede Stater, 43614
        • University of Toledo
      • Toledo, Ohio, Forenede Stater, 43617
        • Toledo Community Hospital Oncology Program CCOP
      • Toledo, Ohio, Forenede Stater, 43608
        • Mercy Health - Saint Vincent Hospital
      • Troy, Ohio, Forenede Stater, 45373
        • Upper Valley Medical Center
      • Troy, Ohio, Forenede Stater, 45373
        • Dayton Physicians LLC - Troy
      • Warren, Ohio, Forenede Stater, 44484
        • Saint Joseph Warren Hospital
      • Wauseon, Ohio, Forenede Stater, 43567
        • Fulton County Health Center
      • West Chester, Ohio, Forenede Stater, 45069
        • University of Cincinnati Cancer Center-West Chester
      • Wright-Patterson Air Force Base, Ohio, Forenede Stater, 45433
        • Wright-Patterson Medical Center
      • Youngstown, Ohio, Forenede Stater, 44501
        • Saint Elizabeth Youngstown Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, Forenede Stater, 73120
        • Mercy Hospital Oklahoma City
    • Oregon
      • Baker City, Oregon, Forenede Stater, 97814
        • Saint Alphonsus Cancer Care Center-Baker City
      • Bend, Oregon, Forenede Stater, 97701
        • Saint Charles Health System
      • Clackamas, Oregon, Forenede Stater, 97015
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, Forenede Stater, 97015
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, Forenede Stater, 97420
        • Bay Area Hospital
      • Newberg, Oregon, Forenede Stater, 97132
        • Providence Newberg Medical Center
      • Ontario, Oregon, Forenede Stater, 97914
        • Saint Alphonsus Cancer Care Center-Ontario
      • Oregon City, Oregon, Forenede Stater, 97045
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, Forenede Stater, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Forenede Stater, 97225
        • Providence Saint Vincent Medical Center
      • Redmond, Oregon, Forenede Stater, 97756
        • Saint Charles Health System-Redmond
    • Pennsylvania
      • Danville, Pennsylvania, Forenede Stater, 17822
        • Geisinger Medical Center
      • Hershey, Pennsylvania, Forenede Stater, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania/Abramson Cancer Center
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
        • UPMC Hillman Cancer Center
      • Scranton, Pennsylvania, Forenede Stater, 18510
        • Community Medical Center
    • South Carolina
      • Anderson, South Carolina, Forenede Stater, 29621
        • AnMed Health Cancer Center
      • Boiling Springs, South Carolina, Forenede Stater, 29316
        • Prisma Health Cancer Institute - Spartanburg
      • Easley, South Carolina, Forenede Stater, 29640
        • Prisma Health Cancer Institute - Easley
      • Gaffney, South Carolina, Forenede Stater, 29341
        • Gibbs Cancer Center-Gaffney
      • Greenville, South Carolina, Forenede Stater, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, Forenede Stater, 29607
        • Saint Francis Cancer Center
      • Greenville, South Carolina, Forenede Stater, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greenville, South Carolina, Forenede Stater, 29605
        • Prisma Health Cancer Institute - Butternut
      • Greenville, South Carolina, Forenede Stater, 29601
        • Saint Francis Hospital
      • Greenville, South Carolina, Forenede Stater, 29605
        • Prisma Health Greenville Memorial Hospital
      • Greenville, South Carolina, Forenede Stater, 29601
        • Greenville Health System Cancer Institute-Andrews
      • Greer, South Carolina, Forenede Stater, 29650
        • Prisma Health Cancer Institute - Greer
      • Greer, South Carolina, Forenede Stater, 29651
        • Gibbs Cancer Center-Pelham
      • Lancaster, South Carolina, Forenede Stater, 29720
        • Carolina Blood and Cancer Care Associates PA-Lancaster
      • Rock Hill, South Carolina, Forenede Stater, 29732
        • Carolina Blood and Cancer Care Associates PA
      • Seneca, South Carolina, Forenede Stater, 29672
        • Prisma Health Cancer Institute - Seneca
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Spartanburg Medical Center
    • Tennessee
      • Franklin, Tennessee, Forenede Stater, 37067
        • Vanderbilt-Ingram Cancer Center Cool Springs
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University/Ingram Cancer Center
      • Nashville, Tennessee, Forenede Stater, 37204
        • Vanderbilt Breast Center at One Hundred Oaks
    • Texas
      • Dallas, Texas, Forenede Stater, 75235
        • Parkland Memorial Hospital
      • Dallas, Texas, Forenede Stater, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Houston, Texas, Forenede Stater, 77030
        • Houston Methodist Hospital
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
      • Houston, Texas, Forenede Stater, 77030
        • Ben Taub General Hospital
    • Utah
      • American Fork, Utah, Forenede Stater, 84003
        • American Fork Hospital / Huntsman Intermountain Cancer Center
      • Cedar City, Utah, Forenede Stater, 84720
        • Sandra L Maxwell Cancer Center
      • Farmington, Utah, Forenede Stater, 84025
        • Farmington Health Center
      • Logan, Utah, Forenede Stater, 84321
        • Logan Regional Hospital
      • Murray, Utah, Forenede Stater, 84107
        • Intermountain Medical Center
      • Ogden, Utah, Forenede Stater, 84403
        • McKay-Dee Hospital Center
      • Provo, Utah, Forenede Stater, 84604
        • Utah Valley Regional Medical Center
      • Riverton, Utah, Forenede Stater, 84065
        • Riverton Hospital
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Huntsman Cancer Institute/University of Utah
      • Salt Lake City, Utah, Forenede Stater, 84106
        • Utah Cancer Specialists-Salt Lake City
      • Salt Lake City, Utah, Forenede Stater, 84143
        • LDS Hospital
      • South Jordan, Utah, Forenede Stater, 84009
        • South Jordan Health Center
      • St. George, Utah, Forenede Stater, 84770
        • Saint George Regional Medical Center
    • Virginia
      • Fredericksburg, Virginia, Forenede Stater, 22401
        • Fredericksburg Oncology Inc
      • Richmond, Virginia, Forenede Stater, 23235
        • VCU Massey Cancer Center at Stony Point
      • Richmond, Virginia, Forenede Stater, 23298
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Aberdeen, Washington, Forenede Stater, 98520
        • Providence Regional Cancer System-Aberdeen
      • Anacortes, Washington, Forenede Stater, 98221
        • Cancer Care Center at Island Hospital
      • Auburn, Washington, Forenede Stater, 98001
        • MultiCare Auburn Medical Center
      • Bellevue, Washington, Forenede Stater, 98004
        • Overlake Medical Center
      • Bellevue, Washington, Forenede Stater, 98005
        • Swedish Cancer Institute-Eastside Oncology Hematology
      • Bellingham, Washington, Forenede Stater, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, Forenede Stater, 98531
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, Forenede Stater, 98026
        • Swedish Cancer Institute-Edmonds
      • Everett, Washington, Forenede Stater, 98201
        • Providence Regional Cancer Partnership
      • Gig Harbor, Washington, Forenede Stater, 98335
        • MultiCare Gig Harbor Medical Park
      • Issaquah, Washington, Forenede Stater, 98029
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, Forenede Stater, 99336
        • Kadlec Clinic Hematology and Oncology
      • Lacey, Washington, Forenede Stater, 98503
        • Providence Regional Cancer System-Lacey
      • Longview, Washington, Forenede Stater, 98632
        • PeaceHealth Saint John Medical Center
      • Port Townsend, Washington, Forenede Stater, 98368
        • Jefferson Healthcare
      • Puyallup, Washington, Forenede Stater, 98372
        • MultiCare Good Samaritan Hospital
      • Renton, Washington, Forenede Stater, 98055
        • Valley Medical Center
      • Seattle, Washington, Forenede Stater, 98107
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, Forenede Stater, 98122
        • Swedish Medical Center-First Hill
      • Seattle, Washington, Forenede Stater, 98112
        • Kaiser Permanente Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Minor and James Medical PLLC
      • Seattle, Washington, Forenede Stater, 98104
        • Pacific Gynecology Specialists
      • Seattle, Washington, Forenede Stater, 98122-5711
        • Swedish Medical Center-Cherry Hill
      • Sedro-Woolley, Washington, Forenede Stater, 98284
        • PeaceHealth United General Medical Center
      • Shelton, Washington, Forenede Stater, 98584
        • Providence Regional Cancer System-Shelton
      • Spokane, Washington, Forenede Stater, 99218
        • Evergreen Hematology and Oncology PS
      • Spokane, Washington, Forenede Stater, 99204
        • MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
      • Spokane, Washington, Forenede Stater, 99218
        • MultiCare Deaconess Cancer and Blood Specialty Center - North
      • Spokane Valley, Washington, Forenede Stater, 99216
        • MultiCare Deaconess Cancer and Blood Specialty Center - Valley
      • Tacoma, Washington, Forenede Stater, 98405
        • Mary Bridge Children's Hospital and Health Center
      • Tacoma, Washington, Forenede Stater, 98405
        • MultiCare Tacoma General Hospital
      • Vancouver, Washington, Forenede Stater, 98664
        • PeaceHealth Southwest Medical Center
      • Walla Walla, Washington, Forenede Stater, 99362
        • Providence Saint Mary Regional Cancer Center
      • Yakima, Washington, Forenede Stater, 98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
      • Yelm, Washington, Forenede Stater, 98597
        • Providence Regional Cancer System-Yelm
    • Wisconsin
      • Eau Claire, Wisconsin, Forenede Stater, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Eau Claire, Wisconsin, Forenede Stater, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Green Bay, Wisconsin, Forenede Stater, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, Forenede Stater, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Gundersen Lutheran Medical Center
      • Madison, Wisconsin, Forenede Stater, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Manitowoc, Wisconsin, Forenede Stater, 54221
        • Holy Family Memorial Hospital
      • Marinette, Wisconsin, Forenede Stater, 54143
        • Saint Vincent Hospital Cancer Center at Marinette
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Medical Center-Marshfield
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Medical Center
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Medical College of Wisconsin
      • Minocqua, Wisconsin, Forenede Stater, 54548
        • Marshfield Medical Center - Minocqua
      • Oconto Falls, Wisconsin, Forenede Stater, 54154
        • Saint Vincent Hospital Cancer Center at Oconto Falls
      • Rice Lake, Wisconsin, Forenede Stater, 54868
        • Marshfield Medical Center-Rice Lake
      • Sheboygan, Wisconsin, Forenede Stater, 53081
        • HSHS Saint Nicholas Hospital
      • Stevens Point, Wisconsin, Forenede Stater, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Sturgeon Bay, Wisconsin, Forenede Stater, 54235-1495
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
      • Wausau, Wisconsin, Forenede Stater, 54401
        • Marshfield Clinic-Wausau Center
      • Weston, Wisconsin, Forenede Stater, 54476
        • Marshfield Medical Center - Weston
    • Wyoming
      • Casper, Wyoming, Forenede Stater, 82609
        • Rocky Mountain Oncology
      • Cheyenne, Wyoming, Forenede Stater, 82001
        • Cheyenne Regional Medical Center-West
      • Cody, Wyoming, Forenede Stater, 82414
        • Big Horn Basin Cancer Center
      • Cody, Wyoming, Forenede Stater, 82414
        • Billings Clinic-Cody
      • Sheridan, Wyoming, Forenede Stater, 82801
        • Welch Cancer Center
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center
  • Puerto Rico
      • Bayamón, Puerto Rico, 00959-5060
        • Cancer Center-Metro Medical Center Bayamon
      • Manati, Puerto Rico, 00674
        • Doctors Cancer Center
      • San Juan, Puerto Rico, 00917
        • San Juan Community Oncology Group
      • San Juan, Puerto Rico, 00927
        • Centro Comprensivo de Cancer de UPR
      • San Juan, Puerto Rico, 00936
        • San Juan City Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

30 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • PRE-REGISTRATION

  • Diagnostic bone marrow and/or peripheral blood specimens must be submitted for immunophenotyping and selected molecular testing, and the establishment of BCR/ABL status; testing will be performed by the Eastern Cooperative Oncology Group (ECOG)-American College of Radiation Imaging Network (ACRIN) Leukemia Translational Research Laboratory (LTRL) and reported to the institution

    • NOTE: IT IS ESSENTIAL THAT A SAMPLE CONTAINING SUFFICIENT BLAST CELLS BE SUBMITTED TO THE ECOG-ACRIN LTRL AT BASELINE SO THAT SUBSEQUENT BONE MARROW ASSESSMENTS OF MRD CAN BE DONE; IN ADDITION TO ALLOWING THE LTRL TO CONFIRM ELIGIBILITY BASED ON BLAST CELL IMMUNOPHENOTYPE AND BCR/ABL STATUS, IT IS ALSO IMPERATIVE THAT AN ADEQUATE NUMBER OF BLASTS BE BANKED FOR ANALYSIS BY DRS MULLIGHAN/WILLMAN. WITHOUT ADEQUATE BASELINE SAMPLES, PATIENTS WILL NOT BE ABLE TO BE TREATED AND RANDOMIZED ON THIS PROTOCOL; IF A BONE MARROW ASPIRATE IS NOT AVAILABLE FOR LTRL SUBMISSION AT BASELINE, IT IS IMPERATIVE THAT DR PAIETTA FROM THE LTRL IS CALLED TO DISCUSS THE PERIPHERAL BLOOD WHITE BLOOD CELL (WBC) AND BLAST COUNT BEFORE BLOOD ONLY IS SUBMITTED
    • NOTE: Hydroxyurea can be given for up to 5 days prior to initiation of protocol therapy for control of leukocyte count and/or other symptoms or signs; corticosteroids can be given after pre-registration to the protocol and submission of baseline marrow and blood samples for control of leukocyte count and/or other symptoms or signs prior to initiation of protocol therapy if needed; if corticosteroids are given prior to pre-registration, contact the study chair as the patient may still be eligible to participate

  • INDUCTION ELIGIBILITY CRITERIA-STEP 1

  • Age >= 30 years and =< 70 years

  • New diagnosis of B lineage ALL must be made upon bone marrow or peripheral blood immunophenotyping; cases with myeloid antigen expression, but unequivocal lymphoid immunophenotype, are eligible

  • Negativity for the Philadelphia chromosome must be established by conventional cytogenetics, fluorescence in situ hybridization (FISH) and/or polymerase chain reaction (PCR); patients who are negative for the Philadelphia chromosome by conventional cytogenetics must have FISH or PCR performed for BCR/ABL to exclude occult translocations

  • Cytogenetic analysis must be performed from diagnostic bone marrow (preferred) or if adequate number of circulating blasts from peripheral blood; FISH testing for common B-lineage ALL abnormalities including t(9;22) (BCR/ABL1), t(12;21) (ETS-variant gene 6 [ETV6]/runt-related transcription factor 1 [RUNX1]), t(1;19) (pre-B-cell leukemia homeobox 1 [PBX1]/transcription factor 3 [TCF3]), +4,+10,+17, (centromeric [Cen]4/Cen10/Cen17), t(11q23;var), (myeloid/lymphoid or mixed lineage leukemia [MLL]), deletion (del)(9p) (cyclin-dependent kinase inhibitor 2A [CDKN2A]/Cen9), and t(14;var) (immunoglobulin heavy chain [IGH] is encouraged); if there are few or no circulating blasts and an adequate marrow sample cannot be obtained for cytogenetic analysis, the patient may still enroll on the trial

  • Serum direct bilirubin < 2 mg/dl or serum total bilirubin =< 3 (obtained =< 48 hours prior to registration); NOTE: the above stipulation for normal hepatic function does not apply if liver dysfunction is due to leukemia infiltration

  • Serum creatinine < 2 mg/dl (obtained =< 48 hours prior to registration); NOTE: the above stipulation for normal hepatic function does not apply if liver dysfunction is due to leukemia infiltration

  • Patient should be human leukocyte antigen (HLA) typed (A, B, C, DR and DQ) during induction therapy phase or a written explanation for not undergoing HLA typing on the flow sheet

  • Patients with known human immunodeficiency virus (HIV) infection are eligible if they meet all of the following criteria:

    • No history of acquired immune deficiency syndrome (AIDS)-related complications other than a history of low CD4+ T-cell count (< 200/mm^3) prior to initiation of combination antiretroviral therapy; on study CD4+ T-cell count may not be informative due to leukemia and should not be used as an exclusion criterion if low
    • Patient must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the leukemia
    • Patient must have serum HIV viral load of < 200 copies/mm^3
    • Patient must be on combination antiretroviral therapy with minimal pharmacokinetic interactions with study therapy and minimal overlapping clinical toxicity with protocol therapy
    • Patient must not be receiving protease inhibitors or once daily formulations containing cobicistat, stavudine, or on regimens containing stavudine or zidovudine
    • It is recommended to utilize a regimen of the integrase inhibitor, dolutegravir, combined with either disoproxil fumarate/emtricitabine or dolutegravir combined with tenofovir alafenamide/emtricitabine

  • Patient must have no history of recent myocardial infarction (within three months), uncontrolled congestive heart failure, or uncontrolled cardiac arrhythmia

  • Patient must have a normal cardiac ejection fraction by pretreatment multigated acquisition scan (MUGA) or echocardiogram within 4 weeks prior to registration (resting ejection fraction >= 40% or >= 5% increase with exercise), shortening fraction by echocardiogram >= 24%, or to within the normal range of values for the institution

  • Women must not be pregnant or breast-feeding due to administration of teratogenic chemotherapy and must not become pregnant or breastfeed during protocol therapy and for at least 3 months after protocol therapy; woman of childbearing potential must abstain from sexual activity or be willing to use 2 highly effective forms of contraception throughout protocol therapy and for at least an additional 3 months after the last dose of protocol-specified therapy; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of whether they have undergone tubal ligation, who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

  • Men who have a female partner of childbearing potential must be willing to use 2 highly effective forms of contraception throughout protocol therapy and for at least an additional 3 months after the last dose of protocol-specified therapy; men who have a pregnant partner must be willing to use a condom during sexual activity throughout protocol therapy and for 3 months after the last dose of protocol-specified therapy

  • ECOG performance score 0-3

  • Patient must have given written informed consent

  • POST-INDUCTION THERAPY ELIGIBILITY CRITERIA (PRIOR TO INTENSIFICATION-STEP 2)

  • ECOG performance status 0-2

  • Patients must have achieved a CR or CRi

  • Patients who have achieved a CR or CRi must have maintained peripheral blood evidence of a CR or CRi

  • Patient must be CNS (cerebrospinal fluid [CSF]) negative for leukemia

  • Patients must have resolved any serious infectious complications related to induction

  • Any significant medical complications related to induction must have resolved

  • Serum creatinine =< 2.0 mg/dl (obtained =< 48 hours prior to registration)

  • Serum direct bilirubin < 2 mg/dL or serum total bilirubin =< 3 (obtained =< 48 hours prior to registration)

  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN) (obtained =< 48 hours prior to registration)

  • RANDOMIZATION OR ASSIGNMENT TO BLINATUMOMAB OR NO BLINATUMOMAB-STEP 3

  • Patients must have an ECOG performance status of 0-2

  • Patients must have maintained peripheral blood evidence of a remission and must have a CR or CRi, confirmed on restaging bone marrow (BM) aspirate and biopsy

  • Patients must have resolved any serious infectious complications related to therapy

  • Any significant medical complications related to therapy must have resolved

  • Direct or total bilirubin < 1.5 x ULN (unless related to Gilbert's or Meulengracht's syndrome); the values must be obtained within 48 hours prior to randomization

  • Serum creatinine < 1.5 x ULN; the values must be obtained within 48 hours prior to randomization

  • Bone marrow aspirates must be submitted for centralized minimal residual disease (MRD) assessment performed by the ECOG-ACRIN Leukemia Translational Research Laboratory

  • MRD results will be reported to the submitting institution

    • NOTE: FOR MRD ASSESSMENTS, AN ASPIRATE FROM A SEPARATE BONE MARROW ASPIRATION SITE MUST BE SUBMITTED (THE NEEDLE CAN BE RE-DIRECTED THROUGH THE SAME SKIN PUNCTURE SITE); ONLY SUBMIT ASPIRATES FROM THE FIRST PULL OF AN ASPIRATION SITE FOR MRD TESTING; DO NOT SUBMIT SAMPLES FROM THE SECOND OR THIRD PULL OF THE SAME ASPIRATION SITE

    • In B-lineage ALL, MRD levels in peripheral blood or from a dilute marrow aspiration can be 300% lower, on average, than those in bone marrow at a given time point; submitting a first pull from a separate aspiration site will ensure that MRD determinations used in randomization and trial interpretation are accurate

      • NOTE: failure to submit bone marrow aspirates will result in a major violation at the time of an audit

  • CRITERIA FOR ALLOGENEIC TRANSPLANTATION

  • A suitable donor must be identified; there are no restrictions on donor type and can include a matched sibling, a matched or mismatched unrelated donor, a family haplotype matched donor or a cord blood donor (single or double)

  • Patients should meet the eligibility criteria for RANDOMIZATION OR ASSIGNMENT TO BLINATUMOMAB OR NO BLINATUMOMAB-STEP 3

  • Patients must be considered reliable enough to comply with the medication regimen and follow-up, and have social support necessary to allow this compliance

  • CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Patients must have an ECOG performance status of 0-3

  • CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Patients must have maintained peripheral blood evidence of a remission and must have a CR or CRi, confirmed on restaging BM aspirate and biopsy

  • CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Patients must have resolved any serious infectious complications related to therapy

  • CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Any significant medical complications related to therapy must have resolved

Exclusion Criteria:

  • Mature B ALL (Burkitt's-like leukemia) is excluded from enrollment in this trial; pre-study bone marrow biopsy and aspirate must be completed =< 1 week prior to registration
  • Patient must not have a concurrent active malignancy for which they are receiving treatment
  • Patient must not have intercurrent organ damage or medical problems that will jeopardize the outcome of therapy (i.e., psychiatric disorder, drug abuse, pregnancy)
  • Patient must not have an antecedent hematologic disorder
  • Patient must not have a history or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia; Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, or other significant CNS abnormalities
  • Patient must not have an active uncontrolled infection

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Arm I (blinatumomab, chemotherapy)

See Detailed Description
Medicin: Cyclophosphamide

Given IV

Andre navne:
  • Cytoxan
  • CTX
  • (-)-Cyclophosphamid
  • 2H-1,3,2-Oxazaphosphorin, 2-[bis(2-chlorethyl)amino]tetrahydro-, 2-oxid, monohydrat
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamid
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrat
  • CYCLO-celle
  • Cykloblastin
  • Cycloblastin
  • Cyclofosfam
  • Cyclophosphamid monohydrat
  • Cyclophosphamid Monohydrat
  • Cyclophospamidum
  • Cyclofosfan
  • Cyclophosphanum
  • Cyclostin
  • Cytophosphan
  • Cytofosfan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimune
  • Syklofosfamid
  • WR- 138719
  • Asta B 518
  • B-518
  • WR-138719
  • B 518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Medicin: Prednisone

Given PO

Andre navne:
  • Deltasone
  • Orasone
  • 81-kortison
  • 1,2-dehydrocortison
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-kortison
  • Delta-Dome
  • Deltacortene
  • Deltacortison
  • Deltadehydrocortison
  • Deltison
  • Delta
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metacortandracin
  • Meticorten
  • Ofisolona
  • Panafcort
  • Panasol-S
  • Paracort
  • Perrigo Prednison
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednison Intensol
  • Prednisonum
  • Predniton
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednison
Procedure: Bone Marrow Biopsy

Undergo bone marrow biopsy

Andre navne:
  • Biopsi af knoglemarv
  • Biopsi, knoglemarv
Procedure: Biospecimen Collection

Undergo blood sample collection

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Biologisk: Rituximab

Given IV

Andre navne:
  • Rituxan
  • MabThera
  • ABP 798
  • BI 695500
  • C2B8 monoklonalt antistof
  • Kimærisk anti-CD20 antistof
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • IDEC-C2B8 monoklonalt antistof
  • Monoklonalt antistof IDEC-C2B8
  • PF-05280586
  • Riabni
  • Rituximab ABBS
  • Rituximab ARRX
  • Rituximab Biosimilar ABP 798
  • Rituximab Biosimilar BI 695500
  • Rituximab Biosimilar CT-P10
  • Rituximab Biosimilar GB241
  • Rituximab Biosimilar IBI301
  • Rituximab Biosimilar JHL1101
  • Rituximab Biosimilar PF-05280586
  • Rituximab Biosimilar RTXM83
  • Rituximab Biosimilar SAIT101
  • Rituximab Biosimilar SIBP-02
  • rituximab biosimilær TQB2303
  • Rituximab PVVR
  • Rituximab-arrx
  • Rituximab-pvvr
  • RTXM83
  • Ruxience
  • Truxima
  • Rixathon
  • Ikgdar
  • Mabtas
  • Rituximab-abbs
  • BI-695500
  • BI695500
  • Blitzima
  • IDEC 102
  • IDEC102
  • PF 05280586
  • PF05280586
  • Ritemvia
  • Rituximab-blit
  • Rituximab-rite
  • Rituximab-rixa
  • Rituximab-rixi
  • Riximyo
  • RTXM 83
  • RTXM-83
  • ABP-798
  • ABP798
  • CT P10
  • CTP10
  • GP 2013
  • GP-2013
  • GP2013
  • Rituximab Biosimilar GP2013
Medicin: Vincristine

Given IV

Andre navne:
  • VCR
  • Leurocristine
  • Vincrystine
  • LCR
Medicin: Vincristine Sulfate

Given IV

Andre navne:
  • Oncovin
  • Kyocristine
  • Leurocristinsulfat
  • Leurocristin, sulfat
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristin, sulfat
Medicin: Dexamethasone

Given PO

Andre navne:
  • Dekadron
  • Hemady
  • Aacideksamen
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decason R.p.
  • Dectancyl
  • Dekacort
  • Deltafluoren
  • Deronil
  • Desamethason
  • Desameton
  • Dexa-Mamallet
  • Dexa-næsehorn
  • Dexa-Scheroson
  • Dexa-sinus
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluoren
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethason Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolon
  • Millicorten
  • Mymethason
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazon
  • ZoDex
  • LenaDex
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic hematopoietic SCT

Andre navne:
  • Allogen
  • Allogen hæmatopoietisk celletransplantation
  • Allogen stamcelletransplantation
  • HSC
  • HSCT
  • Stamcelletransplantation, Allogen
Biologisk: Blinatumomab

Given IV

Andre navne:
  • Blincyto
  • Anti-CD19 x Anti-CD3 bispecifikt monoklonalt antistof
  • Anti-CD19/Anti-CD3 rekombinant bispecifikt monoklonalt antistof MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
  • MEDI 538
  • MT 103
Procedure: Bone Marrow Aspiration

Undergo bone marrow aspiration

Medicin: Cytarabine

Given IT, IV, or SC

Andre navne:
  • Β-Cytosin arabinosid
  • 1-β-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-β-D-Arabinofuranosylcytosin
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-Beta-D-arabinofuranosylcytosin
  • 1β-D-Arabinofuranosylcytosin
  • 2(1H)-pyrimidinon, 4-amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-pyrimidinon, 4-amino-1P-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-celle
  • Arabine
  • Arabinofuranosylcytosin
  • Arabinosylcytosin
  • Aracytidin
  • Aracytin
  • Beta-Cytosin Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosin Arabinoside
  • Cytosin-β-arabinosid
  • Cytosin-beta-arabinosid
  • Erpalfa
  • Starasid
  • Tarabin PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Medicin: Daunorubicin

Given IV

Andre navne:
  • DNR
  • Rubidomycin
  • Daunomycin
  • Daunorrubicina
  • Leukaemomycin C
  • Rubomycin C
Medicin: Daunorubicin Hydrochloride

Given IV

Andre navne:
  • Cerubidin
  • Cloridrato de Daunorubicina
  • Daunoblastin
  • Daunoblastina
  • Daunomycin hydrochlorid
  • Daunomycin, hydrochlorid
  • Daunorubicin.HCl
  • Daunorubicini Hydrochloridum
  • FI-6339
  • Ondena
  • RP-13057
  • Rubidomycin hydrochlorid
  • Rubilem
Medicin: Etoposide

Given IV

Andre navne:
  • Demethyl Epipodophyllotoxin Ethylidin Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16
  • VP 16-213
  • VP-16
  • VP-16-213
  • VP16
  • VP 16213
  • VP-16213
  • VP16213
Medicin: Leucovorin Calcium

Given IV or PO

Andre navne:
  • Wellcovorin
  • folinsyre
  • Adinepar
  • Calcifolin
  • Calcium (6S)-folinat
  • Calciumfolinat
  • Calcium Leucovorin
  • Calfolex
  • Calinat
  • Cehafolin
  • Citofolin
  • Citrec
  • Citrovorum faktor
  • Cromatonbic Folinico
  • Dalisol
  • Disintox
  • Divical
  • Ecofol
  • Emovis
  • Faktor, Citrovorum
  • Flynoken A
  • Folaren
  • Folaxin
  • FOLI-celle
  • Foliben
  • Folidan
  • Folidar
  • Folinac
  • Folinat Calcium
  • Folinsyre Calcium Salt Pentahydrat
  • Folinoral
  • Folinvit
  • Foliplus
  • Folix
  • Imo
  • Lederfolat
  • Lederfolin
  • Leucosar
  • leukovorin
  • Rescufolin
  • Rescuvolin
  • Tonofolin
Procedure: Lumbar Puncture

Undergo lumbar puncture

Andre navne:
  • LP
  • Spinal Tap
Medicin: Mercaptopurine

Given PO

Andre navne:
  • 6 MP
  • Purinethol
  • 3H-Purin-6-thiol
  • 6 Thiohypoxanthin
  • 6 Thiopurin
  • 6-Mercaptopurin
  • 6-Mercaptopurin monohydrat
  • 6-Purinethiol
  • 6-thiopurin
  • 6-thioxopurin
  • 6H-Purin-6-thion, 1,7-dihydro- (9Cl)
  • 7-Mercapto-1,3,4,6-tetrazainden
  • Alti-Mercaptopurin
  • Azathiopurin
  • Bw 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimethol
  • Purin, 6-mercapto-
  • Purin-6-thiol (8CI)
  • Purin-6-thiol, monohydrat
  • Purinethiol
  • U-4748
  • WR-2785
Medicin: Methotrexate

Given PO, IT or IV

Andre navne:
  • Abitrexat
  • Folex
  • Mexate
  • MTX
  • Alpha-Methopterin
  • Amethopterin
  • Brimexat
  • CL 14377
  • CL-14377
  • Emtexat
  • Emthexat
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Ledertrexat
  • Lumexon
  • Maxtrex
  • Medsatrexat
  • Metex
  • Methoblastin
  • Methotrexat LPF
  • Methotrexat Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate-AQ
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
  • Jylamvo
Medicin: Pegaspargase

Given IM or IV

Andre navne:
  • L-asparaginase med polyethylenglycol
  • Oncaspar
  • Oncaspar-IV
  • PEG-asparaginase
  • PEG-L-asparaginase
  • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
  • PEGLA
  • Polyethylenglycol L-Asparaginase
  • Polyethylenglycol-L-Asparaginase
Procedure: X-Ray Imaging

Undergo x-ray imaging

Andre navne:
  • Konventionel røntgen
  • Diagnostisk radiologi
  • Medicinsk billeddannelse, røntgen
  • Radiografisk billeddannelse
  • Radiografi
  • RG
  • Statisk røntgen
  • Røntgen
  • Almindelige film røntgenbilleder
  • Radiografisk billeddannelsesprocedure (procedure)
Aktiv komparator: Arm II (chemotherapy)

See Detailed Description
Medicin: Cyclophosphamide

Given IV

Andre navne:
  • Cytoxan
  • CTX
  • (-)-Cyclophosphamid
  • 2H-1,3,2-Oxazaphosphorin, 2-[bis(2-chlorethyl)amino]tetrahydro-, 2-oxid, monohydrat
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamid
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrat
  • CYCLO-celle
  • Cykloblastin
  • Cycloblastin
  • Cyclofosfam
  • Cyclophosphamid monohydrat
  • Cyclophosphamid Monohydrat
  • Cyclophospamidum
  • Cyclofosfan
  • Cyclophosphanum
  • Cyclostin
  • Cytophosphan
  • Cytofosfan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimune
  • Syklofosfamid
  • WR- 138719
  • Asta B 518
  • B-518
  • WR-138719
  • B 518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Medicin: Prednisone

Given PO

Andre navne:
  • Deltasone
  • Orasone
  • 81-kortison
  • 1,2-dehydrocortison
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-kortison
  • Delta-Dome
  • Deltacortene
  • Deltacortison
  • Deltadehydrocortison
  • Deltison
  • Delta
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metacortandracin
  • Meticorten
  • Ofisolona
  • Panafcort
  • Panasol-S
  • Paracort
  • Perrigo Prednison
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednison Intensol
  • Prednisonum
  • Predniton
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednison
Procedure: Bone Marrow Biopsy

Undergo bone marrow biopsy

Andre navne:
  • Biopsi af knoglemarv
  • Biopsi, knoglemarv
Procedure: Biospecimen Collection

Undergo blood sample collection

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Biologisk: Rituximab

Given IV

Andre navne:
  • Rituxan
  • MabThera
  • ABP 798
  • BI 695500
  • C2B8 monoklonalt antistof
  • Kimærisk anti-CD20 antistof
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • IDEC-C2B8 monoklonalt antistof
  • Monoklonalt antistof IDEC-C2B8
  • PF-05280586
  • Riabni
  • Rituximab ABBS
  • Rituximab ARRX
  • Rituximab Biosimilar ABP 798
  • Rituximab Biosimilar BI 695500
  • Rituximab Biosimilar CT-P10
  • Rituximab Biosimilar GB241
  • Rituximab Biosimilar IBI301
  • Rituximab Biosimilar JHL1101
  • Rituximab Biosimilar PF-05280586
  • Rituximab Biosimilar RTXM83
  • Rituximab Biosimilar SAIT101
  • Rituximab Biosimilar SIBP-02
  • rituximab biosimilær TQB2303
  • Rituximab PVVR
  • Rituximab-arrx
  • Rituximab-pvvr
  • RTXM83
  • Ruxience
  • Truxima
  • Rixathon
  • Ikgdar
  • Mabtas
  • Rituximab-abbs
  • BI-695500
  • BI695500
  • Blitzima
  • IDEC 102
  • IDEC102
  • PF 05280586
  • PF05280586
  • Ritemvia
  • Rituximab-blit
  • Rituximab-rite
  • Rituximab-rixa
  • Rituximab-rixi
  • Riximyo
  • RTXM 83
  • RTXM-83
  • ABP-798
  • ABP798
  • CT P10
  • CTP10
  • GP 2013
  • GP-2013
  • GP2013
  • Rituximab Biosimilar GP2013
Medicin: Vincristine

Given IV

Andre navne:
  • VCR
  • Leurocristine
  • Vincrystine
  • LCR
Medicin: Vincristine Sulfate

Given IV

Andre navne:
  • Oncovin
  • Kyocristine
  • Leurocristinsulfat
  • Leurocristin, sulfat
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristin, sulfat
Medicin: Dexamethasone

Given PO

Andre navne:
  • Dekadron
  • Hemady
  • Aacideksamen
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decason R.p.
  • Dectancyl
  • Dekacort
  • Deltafluoren
  • Deronil
  • Desamethason
  • Desameton
  • Dexa-Mamallet
  • Dexa-næsehorn
  • Dexa-Scheroson
  • Dexa-sinus
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluoren
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethason Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolon
  • Millicorten
  • Mymethason
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazon
  • ZoDex
  • LenaDex
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic hematopoietic SCT

Andre navne:
  • Allogen
  • Allogen hæmatopoietisk celletransplantation
  • Allogen stamcelletransplantation
  • HSC
  • HSCT
  • Stamcelletransplantation, Allogen
Procedure: Bone Marrow Aspiration

Undergo bone marrow aspiration

Medicin: Cytarabine

Given IT, IV, or SC

Andre navne:
  • Β-Cytosin arabinosid
  • 1-β-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-β-D-Arabinofuranosylcytosin
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-Beta-D-arabinofuranosylcytosin
  • 1β-D-Arabinofuranosylcytosin
  • 2(1H)-pyrimidinon, 4-amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-pyrimidinon, 4-amino-1P-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-celle
  • Arabine
  • Arabinofuranosylcytosin
  • Arabinosylcytosin
  • Aracytidin
  • Aracytin
  • Beta-Cytosin Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosin Arabinoside
  • Cytosin-β-arabinosid
  • Cytosin-beta-arabinosid
  • Erpalfa
  • Starasid
  • Tarabin PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Medicin: Daunorubicin

Given IV

Andre navne:
  • DNR
  • Rubidomycin
  • Daunomycin
  • Daunorrubicina
  • Leukaemomycin C
  • Rubomycin C
Medicin: Daunorubicin Hydrochloride

Given IV

Andre navne:
  • Cerubidin
  • Cloridrato de Daunorubicina
  • Daunoblastin
  • Daunoblastina
  • Daunomycin hydrochlorid
  • Daunomycin, hydrochlorid
  • Daunorubicin.HCl
  • Daunorubicini Hydrochloridum
  • FI-6339
  • Ondena
  • RP-13057
  • Rubidomycin hydrochlorid
  • Rubilem
Medicin: Etoposide

Given IV

Andre navne:
  • Demethyl Epipodophyllotoxin Ethylidin Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16
  • VP 16-213
  • VP-16
  • VP-16-213
  • VP16
  • VP 16213
  • VP-16213
  • VP16213
Medicin: Leucovorin Calcium

Given IV or PO

Andre navne:
  • Wellcovorin
  • folinsyre
  • Adinepar
  • Calcifolin
  • Calcium (6S)-folinat
  • Calciumfolinat
  • Calcium Leucovorin
  • Calfolex
  • Calinat
  • Cehafolin
  • Citofolin
  • Citrec
  • Citrovorum faktor
  • Cromatonbic Folinico
  • Dalisol
  • Disintox
  • Divical
  • Ecofol
  • Emovis
  • Faktor, Citrovorum
  • Flynoken A
  • Folaren
  • Folaxin
  • FOLI-celle
  • Foliben
  • Folidan
  • Folidar
  • Folinac
  • Folinat Calcium
  • Folinsyre Calcium Salt Pentahydrat
  • Folinoral
  • Folinvit
  • Foliplus
  • Folix
  • Imo
  • Lederfolat
  • Lederfolin
  • Leucosar
  • leukovorin
  • Rescufolin
  • Rescuvolin
  • Tonofolin
Procedure: Lumbar Puncture

Undergo lumbar puncture

Andre navne:
  • LP
  • Spinal Tap
Medicin: Mercaptopurine

Given PO

Andre navne:
  • 6 MP
  • Purinethol
  • 3H-Purin-6-thiol
  • 6 Thiohypoxanthin
  • 6 Thiopurin
  • 6-Mercaptopurin
  • 6-Mercaptopurin monohydrat
  • 6-Purinethiol
  • 6-thiopurin
  • 6-thioxopurin
  • 6H-Purin-6-thion, 1,7-dihydro- (9Cl)
  • 7-Mercapto-1,3,4,6-tetrazainden
  • Alti-Mercaptopurin
  • Azathiopurin
  • Bw 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimethol
  • Purin, 6-mercapto-
  • Purin-6-thiol (8CI)
  • Purin-6-thiol, monohydrat
  • Purinethiol
  • U-4748
  • WR-2785
Medicin: Methotrexate

Given PO, IT or IV

Andre navne:
  • Abitrexat
  • Folex
  • Mexate
  • MTX
  • Alpha-Methopterin
  • Amethopterin
  • Brimexat
  • CL 14377
  • CL-14377
  • Emtexat
  • Emthexat
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Ledertrexat
  • Lumexon
  • Maxtrex
  • Medsatrexat
  • Metex
  • Methoblastin
  • Methotrexat LPF
  • Methotrexat Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate-AQ
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
  • Jylamvo
Medicin: Pegaspargase

Given IM or IV

Andre navne:
  • L-asparaginase med polyethylenglycol
  • Oncaspar
  • Oncaspar-IV
  • PEG-asparaginase
  • PEG-L-asparaginase
  • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
  • PEGLA
  • Polyethylenglycol L-Asparaginase
  • Polyethylenglycol-L-Asparaginase
Procedure: X-Ray Imaging

Undergo x-ray imaging

Andre navne:
  • Konventionel røntgen
  • Diagnostisk radiologi
  • Medicinsk billeddannelse, røntgen
  • Radiografisk billeddannelse
  • Radiografi
  • RG
  • Statisk røntgen
  • Røntgen
  • Almindelige film røntgenbilleder
  • Radiografisk billeddannelsesprocedure (procedure)

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS) Among Patients Who Were MRD Negative After Induction and Intensification Chemotherapy
Tidsramme: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

Overall survival is defined as the time from randomization to death of any cause.
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relapse-free Survival (RFS) Among Patients Who Were MRD Negative After Induction and Intensification Chemotherapy
Tidsramme: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

RFS was defined as time from randomization to relapse or to death without documentation of relapse. Patients without events were censored at the date of last disease assessment.

Relapse/Persistent Disease

Persistent disease/Relapse following complete remission (CR)/complete remission incomplete (CRi) is defined as:

  • Reappearance or persistence of blasts in the blood
  • Presence of > 5% blasts, not attributable to another cause (e.g., bone marrow regeneration).
  • In the case of isolated CNS relapse such as a positive cytospin examination of CSF, please consult with Study Chair. Perform bone marrow biopsy (if not already done) to confirm presence or lack of medullary relapse.
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
RFS Among of Those Who Are MRD+ at Randomization and Then Convert to MRD- After 2 Cycles of Blinatumomab to Those Patients Who Are MRD- at Randomization and Remain MRD- After 2 Cycles of Blinatumomab or Consolidation Chemotherapy
Tidsramme: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

RFS was defined as time from end of 2 cycles of blinatumomab to relapse or to death without documentation of relapse. Patients without events were censored at the date of last disease assessment.

Relapse/Persistent Disease

Persistent disease/Relapse following complete remission (CR)/complete remission incomplete (CRi) is defined as:

  • Reappearance or persistence of blasts in the blood
  • Presence of > 5% blasts, not attributable to another cause (e.g., bone marrow regeneration).
  • In the case of isolated CNS relapse such as a positive cytospin examination of CSF, please consult with Study Chair. Perform bone marrow biopsy (if not already done) to confirm presence or lack of medullary relapse.
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
OS Among of Those Who Are MRD+ at Randomization and Then Convert to MRD- After 2 Cycles of Blinatumomab to Those Patients Who Are MRD- at Randomization and Remain MRD- After 2 Cycles of Blinatumomab or Consolidation Chemotherapy
Tidsramme: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

OS was defined as time from end of 2 cycles of blinatumomab to death of any cause
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
OS Among MRD Negative Patients Who Proceed to Allogeneic Transplant on Study
Tidsramme: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

OS was defined as time from allogeneic transplant to death of any cause.
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

Andre resultatmål

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To Determine Differences in MRD Kinetics Among Patients With the BCR/ABL1-like B-lineage ALL, and to Compare the OS (and RFS) of Patients With BCR-ABL-like Phenotype With Those Without BCR-ABLlike Phenotype
Tidsramme: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

To determine differences in MRD kinetics among patients with the BCR/ABL1-like B-lineage ALL, and to compare the OS (and RFS) of patients with BCR-ABL-like phenotype with those without BCR-ABLlike phenotype
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
Incidence of Anti-blinatumomab Antibody Formation
Tidsramme: Assessed at baseline, end of 2 cycles of blinatumomab, end of 4 cycles of blinatumomab, and end of blinatumomab treatment

To evaluate the incidence of anti-blinatumomab antibody formation
Assessed at baseline, end of 2 cycles of blinatumomab, end of 4 cycles of blinatumomab, and end of blinatumomab treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
National Cancer Institute (NCI)

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Mark R Litzow, ECOG-ACRIN Cancer Research Group

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
19. maj 2014

Primær færdiggørelse (Faktiske)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
23. juni 2023

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
25. februar 2027

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
2. december 2013

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
2. december 2013

Først opslået (Anslået)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
6. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
13. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
11. november 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • NCI-2013-02229
  • U10CA180820 (U.S. NIH-bevilling/kontrakt)
  • U24CA196172 (U.S. NIH-bevilling/kontrakt)
  • U10CA021115 (U.S. NIH-bevilling/kontrakt)
  • NCI-2013-02229 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • ECOG-E1910
  • E1910 (Anden identifikator: CTEP)
  • PE1910_A08PAMDREVW01
  • E1910 (Anden identifikator: ECOG-ACRIN Cancer Research Group)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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