- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02003222
Kombinasjonskjemoterapi med eller uten Blinatumomab ved behandling av pasienter med nylig diagnostisert BCR-ABL-negativ B-linje Akutt lymfoblastisk leukemi
En fase III randomisert studie av Blinatumomab for nylig diagnostisert BCR-ABL-negativ B-linje Akutt lymfoblastisk leukemi 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.
Studieoversikt
Status
Intervensjon / Behandling
- Legemiddel: Cyclophosphamide
- Legemiddel: Prednisone
- Fremgangsmåte: Bone Marrow Biopsy
- Fremgangsmåte: Biospecimen Collection
- Biologisk: Rituximab
- Legemiddel: Vincristine
- Legemiddel: Vincristine Sulfate
- Legemiddel: Dexamethasone
- Fremgangsmåte: Allogeneic Hematopoietic Stem Cell Transplantation
- Biologisk: Blinatumomab
- Fremgangsmåte: Bone Marrow Aspiration
- Legemiddel: Cytarabine
- Legemiddel: Daunorubicin
- Legemiddel: Daunorubicin Hydrochloride
- Legemiddel: Etoposide
- Legemiddel: Leucovorin Calcium
- Fremgangsmåte: Lumbar Puncture
- Legemiddel: Mercaptopurine
- Legemiddel: Methotrexate
- Legemiddel: Pegaspargase
- Fremgangsmåte: X-Ray Imaging
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Alberta
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Calgary, Alberta, Canada, T2N 5G2
- Arthur J E Child Comprehensive Cancer Centre
-
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 3P1
- Clinical Research Unit at Vancouver Coastal Health Authority
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
- QEII Health Sciences Centre/Nova Scotia Health Authority
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Ontario
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Kingston, Ontario, Canada, K7L 2V7
- Kingston Health Sciences Centre
-
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Quebec
-
Montreal, Quebec, Canada, H1T 2M4
- CIUSSSEMTL-Hopital Maisonneuve-Rosemont
-
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
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-
-
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Alabama
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Birmingham, Alabama, Forente stater, 35233
- University of Alabama at Birmingham Cancer Center
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Alaska
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Anchorage, Alaska, Forente stater, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, Forente stater, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, Forente stater, 99508
- Alaska Oncology and Hematology LLC
-
Anchorage, Alaska, Forente stater, 99508
- Alaska Women's Cancer Care
-
Anchorage, Alaska, Forente stater, 99508
- Anchorage Oncology Centre
-
Anchorage, Alaska, Forente stater, 99508
- Katmai Oncology Group
-
Anchorage, Alaska, Forente stater, 99508
- Providence Alaska Medical Center
-
Anchorage, Alaska, Forente stater, 99504
- Anchorage Radiation Therapy Center
-
Anchorage, Alaska, Forente stater, 99508
- Alaska Regional Hospital
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Fairbanks, Alaska, Forente stater, 99701
- Fairbanks Memorial Hospital
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Arizona
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Kingman, Arizona, Forente stater, 86401
- Kingman Regional Medical Center
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Tucson, Arizona, Forente stater, 85719
- Banner University Medical Center - Tucson
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Tucson, Arizona, Forente stater, 85719
- University of Arizona Cancer Center-North Campus
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Arkansas
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Fort Smith, Arkansas, Forente stater, 72903
- Mercy Hospital Fort Smith
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Little Rock, Arkansas, Forente stater, 72205
- University of Arkansas for Medical Sciences
-
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California
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Arroyo Grande, California, Forente stater, 93420
- PCR Oncology
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Burbank, California, Forente stater, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Clovis, California, Forente stater, 93611
- Community Cancer Institute
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Clovis, California, Forente stater, 93611
- University Oncology Associates
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La Jolla, California, Forente stater, 92093
- UC San Diego Moores Cancer Center
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Orange, California, Forente stater, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
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Palo Alto, California, Forente stater, 94304
- Stanford Cancer Institute Palo Alto
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Colorado
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Aurora, Colorado, Forente stater, 80012
- Rocky Mountain Cancer Centers-Aurora
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Aurora, Colorado, Forente stater, 80012
- The Medical Center of Aurora
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Boulder, Colorado, Forente stater, 80303
- Boulder Community Foothills Hospital
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Boulder, Colorado, Forente stater, 80304
- Rocky Mountain Cancer Centers-Boulder
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Denver, Colorado, Forente stater, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
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Denver, Colorado, Forente stater, 80220
- Rose Medical Center
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Denver, Colorado, Forente stater, 80218
- Rocky Mountain Cancer Centers-Midtown
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Denver, Colorado, Forente stater, 80220
- Rocky Mountain Cancer Centers-Rose
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Denver, Colorado, Forente stater, 80218
- Colorado Blood Cancer Institute
-
Denver, Colorado, Forente stater, 80204
- Cancer Center of Colorado at Sloan's Lake
-
Denver, Colorado, Forente stater, 80209
- The Women's Imaging Center
-
Denver, Colorado, Forente stater, 80206
- National Jewish Health-Main Campus
-
Denver, Colorado, Forente stater, 80220
- Western Surgical Care
-
Denver, Colorado, Forente stater, 80218
- Saint Joseph Hospital - Cancer Centers of Colorado
-
Englewood, Colorado, Forente stater, 80113
- Mountain Blue Cancer Care Center - Swedish
-
Englewood, Colorado, Forente stater, 80113
- Swedish Medical Center
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Golden, Colorado, Forente stater, 80401
- National Jewish Health-Western Hematology Oncology
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Grand Junction, Colorado, Forente stater, 81501
- Saint Mary's Hospital and Regional Medical Center
-
Grand Junction, Colorado, Forente stater, 81505
- Grand Valley Oncology
-
Greeley, Colorado, Forente stater, 80631
- Banner North Colorado Medical Center
-
Lafayette, Colorado, Forente stater, 80026
- Good Samaritan Hospital - Cancer Centers of Colorado
-
Littleton, Colorado, Forente stater, 80120
- Rocky Mountain Cancer Centers-Littleton
-
Lone Tree, Colorado, Forente stater, 80124
- Sky Ridge Medical Center
-
Lone Tree, Colorado, Forente stater, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
-
Loveland, Colorado, Forente stater, 80539
- Banner North Colorado Medical Center - Loveland Campus
-
Thornton, Colorado, Forente stater, 80260
- National Jewish Health-Northern Hematology Oncology
-
Wheat Ridge, Colorado, Forente stater, 80401
- Intermountain Health Lutheran Hospital
-
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Connecticut
-
Hartford, Connecticut, Forente stater, 06105
- Smilow Cancer Hospital Care Center at Saint Francis
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New Haven, Connecticut, Forente stater, 06520
- Yale University
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Torrington, Connecticut, Forente stater, 06790
- Smilow Cancer Hospital-Torrington Care Center
-
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District of Columbia
-
Washington D.C., District of Columbia, Forente stater, 20016
- Sibley Memorial Hospital
-
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Florida
-
Coral Springs, Florida, Forente stater, 33065
- UM Sylvester Comprehensive Cancer Center at Coral Springs
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Deerfield Beach, Florida, Forente stater, 33442
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Hollywood, Florida, Forente stater, 33021
- UM Sylvester Comprehensive Cancer Center at Hollywood
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Jacksonville, Florida, Forente stater, 32207
- Baptist MD Anderson Cancer Center
-
Miami, Florida, Forente stater, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
-
Miami, Florida, Forente stater, 33176
- UM Sylvester Comprehensive Cancer Center at Kendall
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Plantation, Florida, Forente stater, 33324
- UM Sylvester Comprehensive Cancer Center at Plantation
-
Weston, Florida, Forente stater, 33331
- Cleveland Clinic-Weston
-
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Emory University Hospital/Winship Cancer Institute
-
Atlanta, Georgia, Forente stater, 30342
- Northside Hospital
-
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Idaho
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Boise, Idaho, Forente stater, 83706
- Saint Alphonsus Cancer Care Center-Boise
-
Boise, Idaho, Forente stater, 83712
- Saint Luke's Cancer Institute - Boise
-
Caldwell, Idaho, Forente stater, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Forente stater, 83814
- Kootenai Health - Coeur d'Alene
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Emmett, Idaho, Forente stater, 83617
- Walter Knox Memorial Hospital
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Fruitland, Idaho, Forente stater, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Forente stater, 83642
- Idaho Urologic Institute-Meridian
-
Meridian, Idaho, Forente stater, 83642
- Saint Luke's Cancer Institute - Meridian
-
Nampa, Idaho, Forente stater, 83687
- Saint Alphonsus Cancer Care Center-Nampa
-
Nampa, Idaho, Forente stater, 83687
- Saint Luke's Cancer Institute - Nampa
-
Post Falls, Idaho, Forente stater, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, Forente stater, 83864
- Kootenai Clinic Cancer Services - Sandpoint
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Twin Falls, Idaho, Forente stater, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Bloomington, Illinois, Forente stater, 61704
- Illinois CancerCare-Bloomington
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Bloomington, Illinois, Forente stater, 61701
- OSF Saint Joseph Medical Center
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Canton, Illinois, Forente stater, 61520
- Illinois CancerCare-Canton
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Carbondale, Illinois, Forente stater, 62902
- Memorial Hospital of Carbondale
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Carterville, Illinois, Forente stater, 62918
- SIH Cancer Institute
-
Carthage, Illinois, Forente stater, 62321
- Illinois CancerCare-Carthage
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Centralia, Illinois, Forente stater, 62801
- Centralia Oncology Clinic
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Chicago, Illinois, Forente stater, 60611
- Northwestern University
-
Chicago, Illinois, Forente stater, 60637
- University of Chicago Comprehensive Cancer Center
-
Chicago, Illinois, Forente stater, 60612
- University of Illinois
-
Chicago, Illinois, Forente stater, 60608
- Mount Sinai Hospital Medical Center
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Decatur, Illinois, Forente stater, 62526
- Decatur Memorial Hospital
-
Decatur, Illinois, Forente stater, 62526
- Cancer Care Specialists of Illinois - Decatur
-
Dixon, Illinois, Forente stater, 61021
- Illinois CancerCare-Dixon
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Effingham, Illinois, Forente stater, 62401
- Crossroads Cancer Center
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Eureka, Illinois, Forente stater, 61530
- Illinois CancerCare-Eureka
-
Evanston, Illinois, Forente stater, 60201
- NorthShore University HealthSystem-Evanston Hospital
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Galesburg, Illinois, Forente stater, 61401
- Western Illinois Cancer Treatment Center
-
Galesburg, Illinois, Forente stater, 61401
- Illinois CancerCare-Galesburg
-
Glenview, Illinois, Forente stater, 60026
- NorthShore University HealthSystem-Glenbrook Hospital
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Highland Park, Illinois, Forente stater, 60035
- NorthShore University HealthSystem-Highland Park Hospital
-
Highland Park, Illinois, Forente stater, 60035
- Hematology Oncology Associates of Illinois-Highland Park
-
Kankakee, Illinois, Forente stater, 60901
- Presence Saint Mary's Hospital
-
Kewanee, Illinois, Forente stater, 61443
- Illinois CancerCare-Kewanee Clinic
-
Libertyville, Illinois, Forente stater, 60048
- AMG Libertyville - Oncology
-
Macomb, Illinois, Forente stater, 61455
- Illinois CancerCare-Macomb
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Maywood, Illinois, Forente stater, 60153
- Loyola University Medical Center
-
Mount Vernon, Illinois, Forente stater, 62864
- SSM Health Good Samaritan
-
Niles, Illinois, Forente stater, 60714
- Illinois Cancer Specialists-Niles
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O'Fallon, Illinois, Forente stater, 62269
- Cancer Care Center of O'Fallon
-
Ottawa, Illinois, Forente stater, 61350
- Illinois CancerCare-Ottawa Clinic
-
Ottawa, Illinois, Forente stater, 61350
- Radiation Oncology of Northern Illinois
-
Pekin, Illinois, Forente stater, 61554
- Illinois CancerCare-Pekin
-
Pekin, Illinois, Forente stater, 61554
- OSF Saint Francis Radiation Oncology at Pekin
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Peoria, Illinois, Forente stater, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Forente stater, 61637
- OSF Saint Francis Medical Center
-
Peoria, Illinois, Forente stater, 61615
- Illinois CancerCare-Peoria
-
Peoria, Illinois, Forente stater, 61615
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
-
Peru, Illinois, Forente stater, 61354
- Illinois CancerCare-Peru
-
Peru, Illinois, Forente stater, 61354
- Valley Radiation Oncology
-
Princeton, Illinois, Forente stater, 61356
- Illinois CancerCare-Princeton
-
Skokie, Illinois, Forente stater, 60076
- Hematology Oncology Associates of Illinois - Skokie
-
Skokie, Illinois, Forente stater, 60076
- North Shore Medical Center
-
Springfield, Illinois, Forente stater, 62702
- Southern Illinois University School of Medicine
-
Springfield, Illinois, Forente stater, 62702
- Springfield Clinic
-
Springfield, Illinois, Forente stater, 62702
- Central Illinois Hematology Oncology Center
-
Springfield, Illinois, Forente stater, 62781
- Springfield Memorial Hospital
-
Swansea, Illinois, Forente stater, 62226
- Southwest Illinois Health Services LLP
-
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Indiana
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Fort Wayne, Indiana, Forente stater, 46805
- Parkview Hospital Randallia
-
Fort Wayne, Indiana, Forente stater, 46845
- Parkview Regional Medical Center
-
Indianapolis, Indiana, Forente stater, 46237
- Franciscan Health Indianapolis
-
Mooresville, Indiana, Forente stater, 46158
- Franciscan Health Mooresville
-
Richmond, Indiana, Forente stater, 47374
- Reid Health
-
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Iowa
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Ames, Iowa, Forente stater, 50010
- Mary Greeley Medical Center
-
Ames, Iowa, Forente stater, 50010
- McFarland Clinic - Ames
-
Boone, Iowa, Forente stater, 50036
- McFarland Clinic - Boone
-
Fort Dodge, Iowa, Forente stater, 50501
- McFarland Clinic - Trinity Cancer Center
-
Jefferson, Iowa, Forente stater, 50129
- McFarland Clinic - Jefferson
-
Marshalltown, Iowa, Forente stater, 50158
- McFarland Clinic - Marshalltown
-
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Kansas
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Chanute, Kansas, Forente stater, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, Forente stater, 67801
- Cancer Center of Kansas - Dodge City
-
El Dorado, Kansas, Forente stater, 67042
- Cancer Center of Kansas - El Dorado
-
Fort Scott, Kansas, Forente stater, 66701
- Cancer Center of Kansas - Fort Scott
-
Garden City, Kansas, Forente stater, 67846
- Central Care Cancer Center - Garden City
-
Great Bend, Kansas, Forente stater, 67530
- Central Care Cancer Center - Great Bend
-
Independence, Kansas, Forente stater, 67301
- Cancer Center of Kansas-Independence
-
Kansas City, Kansas, Forente stater, 66160
- University of Kansas Cancer Center
-
Kingman, Kansas, Forente stater, 67068
- Cancer Center of Kansas-Kingman
-
Lawrence, Kansas, Forente stater, 66044
- Lawrence Memorial Hospital
-
Lenexa, Kansas, Forente stater, 66219
- Kansas Institute of Medicine Cancer and Blood Center
-
Lenexa, Kansas, Forente stater, 66219
- Minimally Invasive Surgery Hospital
-
Liberal, Kansas, Forente stater, 67905
- Cancer Center of Kansas-Liberal
-
Manhattan, Kansas, Forente stater, 66502
- Cancer Center of Kansas-Manhattan
-
McPherson, Kansas, Forente stater, 67460
- Cancer Center of Kansas - McPherson
-
Newton, Kansas, Forente stater, 67114
- Cancer Center of Kansas - Newton
-
Olathe, Kansas, Forente stater, 66061
- The University of Kansas Cancer Center - Olathe
-
Overland Park, Kansas, Forente stater, 66209
- Menorah Medical Center
-
Overland Park, Kansas, Forente stater, 66213
- Saint Luke's South Hospital
-
Parsons, Kansas, Forente stater, 67357
- Cancer Center of Kansas - Parsons
-
Pratt, Kansas, Forente stater, 67124
- Cancer Center of Kansas - Pratt
-
Salina, Kansas, Forente stater, 67401
- Cancer Center of Kansas - Salina
-
Wellington, Kansas, Forente stater, 67152
- Cancer Center of Kansas - Wellington
-
Westwood, Kansas, Forente stater, 66205
- University of Kansas Hospital-Westwood Cancer Center
-
Wichita, Kansas, Forente stater, 67214
- Ascension Via Christi Hospitals Wichita
-
Wichita, Kansas, Forente stater, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
-
Wichita, Kansas, Forente stater, 67214
- Cancer Center of Kansas - Wichita
-
Wichita, Kansas, Forente stater, 67208
- Associates In Womens Health
-
Wichita, Kansas, Forente stater, 67214
- Wesley Medical Center
-
Winfield, Kansas, Forente stater, 67156
- Cancer Center of Kansas - Winfield
-
-
Kentucky
-
Crestview Hills, Kentucky, Forente stater, 41017
- Oncology Hematology Care Inc-Crestview
-
Louisville, Kentucky, Forente stater, 40202
- The James Graham Brown Cancer Center at University of Louisville
-
-
Louisiana
-
Baton Rouge, Louisiana, Forente stater, 70809
- Ochsner Health Center-Summa
-
Baton Rouge, Louisiana, Forente stater, 70816
- Medical Center of Baton Rouge
-
Baton Rouge, Louisiana, Forente stater, 70836
- Ochsner High Grove
-
Monroe, Louisiana, Forente stater, 71202
- Ochsner LSU Health Monroe Medical Center
-
New Orleans, Louisiana, Forente stater, 70121
- Ochsner Medical Center Jefferson
-
Shreveport, Louisiana, Forente stater, 71103
- LSU Health Sciences Center at Shreveport
-
-
Maine
-
Bangor, Maine, Forente stater, 04401
- Eastern Maine Medical Center
-
Brewer, Maine, Forente stater, 04412
- Lafayette Family Cancer Center-EMMC
-
-
Maryland
-
Baltimore, Maryland, Forente stater, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
-
Baltimore, Maryland, Forente stater, 21201
- University of Maryland/Greenebaum Cancer Center
-
Bethesda, Maryland, Forente stater, 20889-5600
- Walter Reed National Military Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02215
- Beth Israel Deaconess Medical Center
-
Boston, Massachusetts, Forente stater, 02215
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital Cancer Center
-
-
Michigan
-
Adrian, Michigan, Forente stater, 49221
- Bixby Medical Center
-
Adrian, Michigan, Forente stater, 49221
- Hickman Cancer Center
-
Ann Arbor, Michigan, Forente stater, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
-
Battle Creek, Michigan, Forente stater, 49017
- Bronson Battle Creek
-
Brownstown, Michigan, Forente stater, 48183
- Henry Ford Cancer Institute-Downriver
-
Clinton Township, Michigan, Forente stater, 48038
- Henry Ford Macomb Hospital-Clinton Township
-
Dearborn, Michigan, Forente stater, 48126
- Henry Ford Medical Center-Fairlane
-
Dearborn, Michigan, Forente stater, 48124
- Corewell Health Dearborn Hospital
-
Detroit, Michigan, Forente stater, 48202
- Henry Ford Hospital
-
Detroit, Michigan, Forente stater, 48201
- Wayne State University/Karmanos Cancer Institute
-
Detroit, Michigan, Forente stater, 48236
- Henry Ford Health Saint John Hospital
-
Escanaba, Michigan, Forente stater, 49829
- OSF Saint Francis Hospital and Medical Group
-
Farmington Hills, Michigan, Forente stater, 48334
- Weisberg Cancer Treatment Center
-
Farmington Hills, Michigan, Forente stater, 48336
- Corewell Health Farmington Hills Hospital
-
Flint, Michigan, Forente stater, 48503
- Hurley Medical Center
-
Flint, Michigan, Forente stater, 48503
- Genesys Hurley Cancer Institute
-
Grand Rapids, Michigan, Forente stater, 49503
- Trinity Health Grand Rapids Hospital
-
Grand Rapids, Michigan, Forente stater, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
-
Grand Rapids, Michigan, Forente stater, 49503
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
-
Grosse Pointe, Michigan, Forente stater, 48230
- William Beaumont Hospital-Grosse Pointe
-
Jackson, Michigan, Forente stater, 49201
- Allegiance Health
-
Kalamazoo, Michigan, Forente stater, 49007
- West Michigan Cancer Center
-
Kalamazoo, Michigan, Forente stater, 49007
- Bronson Methodist Hospital
-
Kalamazoo, Michigan, Forente stater, 49048
- Beacon Kalamazoo
-
Lansing, Michigan, Forente stater, 48912
- University of Michigan Health - Sparrow Lansing
-
Livonia, Michigan, Forente stater, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Monroe, Michigan, Forente stater, 48162
- Mercy Memorial Hospital
-
Monroe, Michigan, Forente stater, 48162
- Toledo Clinic Cancer Centers-Monroe
-
Muskegon, Michigan, Forente stater, 49444
- Trinity Health Muskegon Hospital
-
Niles, Michigan, Forente stater, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
-
Norton Shores, Michigan, Forente stater, 49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
-
Novi, Michigan, Forente stater, 48377
- Henry Ford Medical Center-Columbus
-
Pontiac, Michigan, Forente stater, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
Port Huron, Michigan, Forente stater, 48060
- Lake Huron Medical Center
-
Port Huron, Michigan, Forente stater, 48060
- Huron Medical Center PC
-
Reed City, Michigan, Forente stater, 49677
- Corewell Health Reed City Hospital
-
Roseville, Michigan, Forente stater, 48066
- Michigan Cancer Specialists
-
Royal Oak, Michigan, Forente stater, 48073
- Cancer Care Associates PC
-
Royal Oak, Michigan, Forente stater, 48073
- Comprehensive Medical Center PLLC
-
Royal Oak, Michigan, Forente stater, 48073
- Oakland Medical Group
-
Royal Oak, Michigan, Forente stater, 48067
- Oakland Colon Rectal Associates
-
Royal Oak, Michigan, Forente stater, 48073
- Hematology Oncology Consultants PC-Royal Oak
-
Royal Oak, Michigan, Forente stater, 48073
- Corewell Health William Beaumont University Hospital
-
Saginaw, Michigan, Forente stater, 48601
- MyMichigan Medical Center Saginaw
-
Saint Joseph, Michigan, Forente stater, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
-
Saint Joseph, Michigan, Forente stater, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
-
Sterling Heights, Michigan, Forente stater, 48312
- Premier Hematology Oncology Care
-
Sterling Heights, Michigan, Forente stater, 48314
- Mitchell Folbe MD PC
-
Traverse City, Michigan, Forente stater, 49684
- Munson Medical Center
-
Troy, Michigan, Forente stater, 48084
- Michigan Institute of Urology-Town Center
-
Troy, Michigan, Forente stater, 48085
- Claudia BR Herke MD PC
-
Troy, Michigan, Forente stater, 48098
- Hematology Oncology Consultants PC-Troy
-
Troy, Michigan, Forente stater, 48085
- Corewell Health Beaumont Troy Hospital
-
Warren, Michigan, Forente stater, 48093
- Henry Ford Health Warren Hospital
-
West Bloomfield, Michigan, Forente stater, 48322
- Henry Ford West Bloomfield Hospital
-
Wyoming, Michigan, Forente stater, 49519
- University of Michigan Health - West
-
-
Minnesota
-
Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic in Rochester
-
-
Missouri
-
Ballwin, Missouri, Forente stater, 63011
- Mercy Oncology and Hematology - Clayton-Clarkson
-
Bolivar, Missouri, Forente stater, 65613
- Central Care Cancer Center - Bolivar
-
Bonne Terre, Missouri, Forente stater, 63628
- Parkland Health Center-Bonne Terre
-
Branson, Missouri, Forente stater, 65616
- Cox Cancer Center Branson
-
Cape Girardeau, Missouri, Forente stater, 63703
- Saint Francis Medical Center
-
Cape Girardeau, Missouri, Forente stater, 63703
- Mercy Cancer Center - Cape Girardeau
-
City of Saint Peters, Missouri, Forente stater, 63376
- Siteman Cancer Center at Saint Peters Hospital
-
Creve Coeur, Missouri, Forente stater, 63141
- Siteman Cancer Center at West County Hospital
-
Farmington, Missouri, Forente stater, 63640
- Parkland Health Center - Farmington
-
Independence, Missouri, Forente stater, 64057
- Centerpoint Medical Center LLC
-
Jefferson City, Missouri, Forente stater, 65109
- MU Health Care Goldschmidt Cancer Center
-
Joplin, Missouri, Forente stater, 64804
- Freeman Health System
-
Joplin, Missouri, Forente stater, 64804
- Mercy Hospital Joplin
-
Kansas City, Missouri, Forente stater, 64111
- Saint Luke's Hospital of Kansas City
-
Kansas City, Missouri, Forente stater, 64132
- Research Medical Center
-
Kansas City, Missouri, Forente stater, 64118
- Heartland Hematology and Oncology Associates Incorporated
-
Lee's Summit, Missouri, Forente stater, 64086
- Saint Luke's East - Lee's Summit
-
Liberty, Missouri, Forente stater, 64068
- Liberty Hospital
-
Rolla, Missouri, Forente stater, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
-
Rolla, Missouri, Forente stater, 65401
- Phelps Health Delbert Day Cancer Institute
-
Saint Joseph, Missouri, Forente stater, 64506
- Heartland Regional Medical Center
-
Sainte Genevieve, Missouri, Forente stater, 63670
- Sainte Genevieve County Memorial Hospital
-
Springfield, Missouri, Forente stater, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, Forente stater, 65804
- Mercy Hospital Springfield
-
St Louis, Missouri, Forente stater, 63110
- Washington University School of Medicine
-
St Louis, Missouri, Forente stater, 63129
- Siteman Cancer Center-South County
-
St Louis, Missouri, Forente stater, 63131
- Missouri Baptist Medical Center
-
St Louis, Missouri, Forente stater, 63109
- Mercy Infusion Center - Chippewa
-
St Louis, Missouri, Forente stater, 63141
- Mercy Hospital Saint Louis
-
St Louis, Missouri, Forente stater, 63128
- Mercy Hospital South
-
Sullivan, Missouri, Forente stater, 63080
- Missouri Baptist Sullivan Hospital
-
Washington, Missouri, Forente stater, 63090
- Mercy Hospital Washington
-
-
Montana
-
Anaconda, Montana, Forente stater, 59711
- Community Hospital of Anaconda
-
Billings, Montana, Forente stater, 59101
- Billings Clinic Cancer Center
-
Billings, Montana, Forente stater, 59101
- Saint Vincent Healthcare
-
Billings, Montana, Forente stater, 59102
- Saint Vincent Frontier Cancer Center
-
Bozeman, Montana, Forente stater, 59715
- Bozeman Health Deaconess Hospital
-
Butte, Montana, Forente stater, 59701
- Saint James Community Hospital and Cancer Treatment Center
-
Great Falls, Montana, Forente stater, 59405
- Great Falls Clinic
-
Great Falls, Montana, Forente stater, 59405
- Benefis Sletten Cancer Institute
-
Helena, Montana, Forente stater, 59601
- Saint Peter's Community Hospital
-
Kalispell, Montana, Forente stater, 59901
- Logan Health Medical Center
-
Missoula, Montana, Forente stater, 59802
- Saint Patrick Hospital - Community Hospital
-
Missoula, Montana, Forente stater, 59804
- Community Medical Center
-
-
Nebraska
-
Bellevue, Nebraska, Forente stater, 68123
- Nebraska Medicine-Bellevue
-
Omaha, Nebraska, Forente stater, 68198
- University of Nebraska Medical Center
-
Omaha, Nebraska, Forente stater, 68118
- Nebraska Medicine-Village Pointe
-
-
Nevada
-
Carson City, Nevada, Forente stater, 89703
- Carson Tahoe Regional Medical Center
-
Henderson, Nevada, Forente stater, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
Henderson, Nevada, Forente stater, 89052
- Cancer and Blood Specialists-Henderson
-
Henderson, Nevada, Forente stater, 89052
- Las Vegas Cancer Center-Henderson
-
Henderson, Nevada, Forente stater, 89074
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
-
Henderson, Nevada, Forente stater, 89052
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
-
Henderson, Nevada, Forente stater, 89074
- Las Vegas Urology - Green Valley
-
Henderson, Nevada, Forente stater, 89074
- Las Vegas Urology - Pebble
-
Henderson, Nevada, Forente stater, 89074
- Urology Specialists of Nevada - Green Valley
-
Henderson, Nevada, Forente stater, 89074
- Oncology Las Vegas - Henderson
-
Las Vegas, Nevada, Forente stater, 89144
- Summerlin Hospital Medical Center
-
Las Vegas, Nevada, Forente stater, 89109
- Sunrise Hospital and Medical Center
-
Las Vegas, Nevada, Forente stater, 89102
- OptumCare Cancer Care at Charleston
-
Las Vegas, Nevada, Forente stater, 89106
- Radiation Oncology Centers of Nevada Central
-
Las Vegas, Nevada, Forente stater, 89119
- Radiation Oncology Centers of Nevada Southeast
-
Las Vegas, Nevada, Forente stater, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
-
Las Vegas, Nevada, Forente stater, 89128
- OptumCare Cancer Care at MountainView
-
Las Vegas, Nevada, Forente stater, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
-
Las Vegas, Nevada, Forente stater, 89144
- Comprehensive Cancer Centers of Nevada - Town Center
-
Las Vegas, Nevada, Forente stater, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, Forente stater, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Forente stater, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
-
Las Vegas, Nevada, Forente stater, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, Forente stater, 89106
- Cancer and Blood Specialists-Shadow
-
Las Vegas, Nevada, Forente stater, 89109
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
-
Las Vegas, Nevada, Forente stater, 89113
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
-
Las Vegas, Nevada, Forente stater, 89121
- Cancer Therapy and Integrative Medicine
-
Las Vegas, Nevada, Forente stater, 89128
- Cancer and Blood Specialists-Tenaya
-
Las Vegas, Nevada, Forente stater, 89128
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
-
Las Vegas, Nevada, Forente stater, 89148-2405
- Las Vegas Cancer Center-Medical Center
-
Las Vegas, Nevada, Forente stater, 89149
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
-
Las Vegas, Nevada, Forente stater, 89128
- Ann M Wierman MD LTD
-
Las Vegas, Nevada, Forente stater, 89074
- Las Vegas Urology - Pecos
-
Las Vegas, Nevada, Forente stater, 89102
- Desert West Surgery
-
Las Vegas, Nevada, Forente stater, 89103
- Hope Cancer Care of Nevada
-
Las Vegas, Nevada, Forente stater, 89106
- Urology Specialists of Nevada - Central
-
Las Vegas, Nevada, Forente stater, 89113
- Las Vegas Prostate Cancer Center
-
Las Vegas, Nevada, Forente stater, 89113
- Las Vegas Urology - Sunset
-
Las Vegas, Nevada, Forente stater, 89128
- Las Vegas Urology - Cathedral Rock
-
Las Vegas, Nevada, Forente stater, 89128
- Las Vegas Urology - Smoke Ranch
-
Las Vegas, Nevada, Forente stater, 89128
- Urology Specialists of Nevada - Northwest
-
Las Vegas, Nevada, Forente stater, 89169
- University Cancer Center
-
Las Vegas, Nevada, Forente stater, 89113
- Urology Specialists of Nevada - Southwest
-
Las Vegas, Nevada, Forente stater, 89128
- Oncology Las Vegas - Tenaya
-
Las Vegas, Nevada, Forente stater, 89183
- OptumCare Cancer Care at Fort Apache
-
Pahrump, Nevada, Forente stater, 89048
- Hope Cancer Care of Nevada-Pahrump
-
Reno, Nevada, Forente stater, 89502
- Renown Regional Medical Center
-
Reno, Nevada, Forente stater, 89503
- Saint Mary's Regional Medical Center
-
Reno, Nevada, Forente stater, 89509
- Radiation Oncology Associates
-
-
New Hampshire
-
Lebanon, New Hampshire, Forente stater, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
-
New Jersey
-
Basking Ridge, New Jersey, Forente stater, 07920
- Memorial Sloan Kettering Basking Ridge
-
Middletown, New Jersey, Forente stater, 07748
- Memorial Sloan Kettering Monmouth
-
Montvale, New Jersey, Forente stater, 07645
- Memorial Sloan Kettering Bergen
-
New Brunswick, New Jersey, Forente stater, 08903
- Rutgers Cancer Institute of New Jersey
-
-
New York
-
Buffalo, New York, Forente stater, 14263
- Roswell Park Cancer Institute
-
Commack, New York, Forente stater, 11725
- Memorial Sloan Kettering Commack
-
Harrison, New York, Forente stater, 10604
- Memorial Sloan Kettering Westchester
-
Lake Success, New York, Forente stater, 11042
- Northwell Health/Center for Advanced Medicine
-
Manhasset, New York, Forente stater, 11030
- North Shore University Hospital
-
New Hyde Park, New York, Forente stater, 11040
- Long Island Jewish Medical Center
-
New York, New York, Forente stater, 10065
- Memorial Sloan Kettering Cancer Center
-
Rochester, New York, Forente stater, 14642
- University of Rochester
-
Stony Brook, New York, Forente stater, 11794
- Stony Brook University Medical Center
-
The Bronx, New York, Forente stater, 10461
- Montefiore Medical Center-Einstein Campus
-
The Bronx, New York, Forente stater, 10467
- Montefiore Medical Center - Moses Campus
-
The Bronx, New York, Forente stater, 10461
- Montefiore Medical Center-Weiler Hospital
-
Uniondale, New York, Forente stater, 11553
- Memorial Sloan Kettering Nassau
-
-
North Carolina
-
Asheville, North Carolina, Forente stater, 28803
- AdventHealth Infusion Center Asheville
-
Chapel Hill, North Carolina, Forente stater, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Clyde, North Carolina, Forente stater, 28721
- AdventHealth Infusion Center Haywood
-
Hendersonville, North Carolina, Forente stater, 28792
- AdventHealth Hendersonville
-
Winston-Salem, North Carolina, Forente stater, 27157
- Wake Forest University Health Sciences
-
-
Ohio
-
Beavercreek, Ohio, Forente stater, 45431
- Indu and Raj Soin Medical Center
-
Boardman, Ohio, Forente stater, 44512
- Saint Elizabeth Boardman Hospital
-
Bowling Green, Ohio, Forente stater, 43402
- Toledo Clinic Cancer Centers-Bowling Green
-
Centerville, Ohio, Forente stater, 45459
- Miami Valley Hospital South
-
Centerville, Ohio, Forente stater, 45459
- Dayton Physicians LLC-Miami Valley South
-
Cincinnati, Ohio, Forente stater, 45219
- University of Cincinnati Cancer Center-UC Medical Center
-
Cincinnati, Ohio, Forente stater, 45242
- Oncology Hematology Care Inc-Blue Ash
-
Cincinnati, Ohio, Forente stater, 45202
- Oncology Hematology Care Inc-Eden Park
-
Cincinnati, Ohio, Forente stater, 45211
- Oncology Hematology Care Inc-Mercy West
-
Cincinnati, Ohio, Forente stater, 45230
- Oncology Hematology Care Inc-Anderson
-
Cincinnati, Ohio, Forente stater, 45236
- Oncology Hematology Care Inc-Kenwood
-
Cleveland, Ohio, Forente stater, 44106
- Case Western Reserve University
-
Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic Foundation
-
Columbus, Ohio, Forente stater, 43210
- Ohio State University Comprehensive Cancer Center
-
Dayton, Ohio, Forente stater, 45406
- Good Samaritan Hospital - Dayton
-
Dayton, Ohio, Forente stater, 45409
- Miami Valley Hospital
-
Dayton, Ohio, Forente stater, 45415
- Miami Valley Hospital North
-
Dayton, Ohio, Forente stater, 45415
- Dayton Physician LLC - Englewood
-
Fairfield, Ohio, Forente stater, 45014
- Oncology Hematology Care Inc-Healthplex
-
Findlay, Ohio, Forente stater, 45840
- Blanchard Valley Hospital
-
Findlay, Ohio, Forente stater, 45840
- Armes Family Cancer Center
-
Findlay, Ohio, Forente stater, 45840
- Orion Cancer Care
-
Franklin, Ohio, Forente stater, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Franklin, Ohio, Forente stater, 45005
- Dayton Physicians LLC-Atrium
-
Greenville, Ohio, Forente stater, 45331
- Wayne Hospital
-
Greenville, Ohio, Forente stater, 45331
- Dayton Physicians LLC-Wayne
-
Kettering, Ohio, Forente stater, 45429
- Kettering Medical Center
-
Kettering, Ohio, Forente stater, 45409
- Greater Dayton Cancer Center
-
Kettering, Ohio, Forente stater, 45420
- First Dayton Cancer Care
-
Lima, Ohio, Forente stater, 45804
- Lima Memorial Hospital
-
Maumee, Ohio, Forente stater, 43537
- Toledo Clinic Cancer Centers-Maumee
-
Maumee, Ohio, Forente stater, 43537
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
-
Middletown, Ohio, Forente stater, 45042
- Dayton Physicians LLC-Signal Point
-
Oregon, Ohio, Forente stater, 43616
- Saint Charles Hospital
-
Oregon, Ohio, Forente stater, 43616
- Toledo Clinic Cancer Centers-Oregon
-
Sidney, Ohio, Forente stater, 45365
- Dayton Physicians LLC-Wilson
-
Springfield, Ohio, Forente stater, 45504
- Springfield Regional Cancer Center
-
Springfield, Ohio, Forente stater, 45504
- Springfield Regional Medical Center
-
Sylvania, Ohio, Forente stater, 43560
- ProMedica Flower Hospital
-
Tiffin, Ohio, Forente stater, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Forente stater, 43606
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
-
Toledo, Ohio, Forente stater, 43623
- Mercy Health - Saint Anne Hospital
-
Toledo, Ohio, Forente stater, 43623
- Toledo Clinic Cancer Centers-Toledo
-
Toledo, Ohio, Forente stater, 43614
- University of Toledo
-
Toledo, Ohio, Forente stater, 43617
- Toledo Community Hospital Oncology Program CCOP
-
Toledo, Ohio, Forente stater, 43608
- Mercy Health - Saint Vincent Hospital
-
Troy, Ohio, Forente stater, 45373
- Upper Valley Medical Center
-
Troy, Ohio, Forente stater, 45373
- Dayton Physicians LLC - Troy
-
Warren, Ohio, Forente stater, 44484
- Saint Joseph Warren Hospital
-
Wauseon, Ohio, Forente stater, 43567
- Fulton County Health Center
-
West Chester, Ohio, Forente stater, 45069
- University of Cincinnati Cancer Center-West Chester
-
Wright-Patterson Air Force Base, Ohio, Forente stater, 45433
- Wright-Patterson Medical Center
-
Youngstown, Ohio, Forente stater, 44501
- Saint Elizabeth Youngstown Hospital
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forente stater, 73104
- University of Oklahoma Health Sciences Center
-
Oklahoma City, Oklahoma, Forente stater, 73120
- Mercy Hospital Oklahoma City
-
-
Oregon
-
Baker City, Oregon, Forente stater, 97814
- Saint Alphonsus Cancer Care Center-Baker City
-
Bend, Oregon, Forente stater, 97701
- Saint Charles Health System
-
Clackamas, Oregon, Forente stater, 97015
- Clackamas Radiation Oncology Center
-
Clackamas, Oregon, Forente stater, 97015
- Providence Cancer Institute Clackamas Clinic
-
Coos Bay, Oregon, Forente stater, 97420
- Bay Area Hospital
-
Newberg, Oregon, Forente stater, 97132
- Providence Newberg Medical Center
-
Ontario, Oregon, Forente stater, 97914
- Saint Alphonsus Cancer Care Center-Ontario
-
Oregon City, Oregon, Forente stater, 97045
- Providence Willamette Falls Medical Center
-
Portland, Oregon, Forente stater, 97213
- Providence Portland Medical Center
-
Portland, Oregon, Forente stater, 97225
- Providence Saint Vincent Medical Center
-
Redmond, Oregon, Forente stater, 97756
- Saint Charles Health System-Redmond
-
-
Pennsylvania
-
Danville, Pennsylvania, Forente stater, 17822
- Geisinger Medical Center
-
Hershey, Pennsylvania, Forente stater, 17033-0850
- Penn State Milton S Hershey Medical Center
-
Philadelphia, Pennsylvania, Forente stater, 19111
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Forente stater, 19107
- Thomas Jefferson University Hospital
-
Philadelphia, Pennsylvania, Forente stater, 19104
- University of Pennsylvania/Abramson Cancer Center
-
Pittsburgh, Pennsylvania, Forente stater, 15232
- UPMC Hillman Cancer Center
-
Scranton, Pennsylvania, Forente stater, 18510
- Community Medical Center
-
-
South Carolina
-
Anderson, South Carolina, Forente stater, 29621
- AnMed Health Cancer Center
-
Boiling Springs, South Carolina, Forente stater, 29316
- Prisma Health Cancer Institute - Spartanburg
-
Easley, South Carolina, Forente stater, 29640
- Prisma Health Cancer Institute - Easley
-
Gaffney, South Carolina, Forente stater, 29341
- Gibbs Cancer Center-Gaffney
-
Greenville, South Carolina, Forente stater, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, Forente stater, 29607
- Saint Francis Cancer Center
-
Greenville, South Carolina, Forente stater, 29615
- Prisma Health Cancer Institute - Eastside
-
Greenville, South Carolina, Forente stater, 29605
- Prisma Health Cancer Institute - Butternut
-
Greenville, South Carolina, Forente stater, 29601
- Saint Francis Hospital
-
Greenville, South Carolina, Forente stater, 29605
- Prisma Health Greenville Memorial Hospital
-
Greenville, South Carolina, Forente stater, 29601
- Greenville Health System Cancer Institute-Andrews
-
Greer, South Carolina, Forente stater, 29650
- Prisma Health Cancer Institute - Greer
-
Greer, South Carolina, Forente stater, 29651
- Gibbs Cancer Center-Pelham
-
Lancaster, South Carolina, Forente stater, 29720
- Carolina Blood and Cancer Care Associates PA-Lancaster
-
Rock Hill, South Carolina, Forente stater, 29732
- Carolina Blood and Cancer Care Associates PA
-
Seneca, South Carolina, Forente stater, 29672
- Prisma Health Cancer Institute - Seneca
-
Spartanburg, South Carolina, Forente stater, 29303
- Spartanburg Medical Center
-
-
Tennessee
-
Franklin, Tennessee, Forente stater, 37067
- Vanderbilt-Ingram Cancer Center Cool Springs
-
Nashville, Tennessee, Forente stater, 37232
- Vanderbilt University/Ingram Cancer Center
-
Nashville, Tennessee, Forente stater, 37204
- Vanderbilt Breast Center at One Hundred Oaks
-
-
Texas
-
Dallas, Texas, Forente stater, 75235
- Parkland Memorial Hospital
-
Dallas, Texas, Forente stater, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Houston, Texas, Forente stater, 77030
- Houston Methodist Hospital
-
Houston, Texas, Forente stater, 77030
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
-
Houston, Texas, Forente stater, 77030
- Ben Taub General Hospital
-
-
Utah
-
American Fork, Utah, Forente stater, 84003
- American Fork Hospital / Huntsman Intermountain Cancer Center
-
Cedar City, Utah, Forente stater, 84720
- Sandra L Maxwell Cancer Center
-
Farmington, Utah, Forente stater, 84025
- Farmington Health Center
-
Logan, Utah, Forente stater, 84321
- Logan Regional Hospital
-
Murray, Utah, Forente stater, 84107
- Intermountain Medical Center
-
Ogden, Utah, Forente stater, 84403
- McKay-Dee Hospital Center
-
Provo, Utah, Forente stater, 84604
- Utah Valley Regional Medical Center
-
Riverton, Utah, Forente stater, 84065
- Riverton Hospital
-
Salt Lake City, Utah, Forente stater, 84112
- Huntsman Cancer Institute/University of Utah
-
Salt Lake City, Utah, Forente stater, 84106
- Utah Cancer Specialists-Salt Lake City
-
Salt Lake City, Utah, Forente stater, 84143
- LDS Hospital
-
South Jordan, Utah, Forente stater, 84009
- South Jordan Health Center
-
St. George, Utah, Forente stater, 84770
- Saint George Regional Medical Center
-
-
Virginia
-
Fredericksburg, Virginia, Forente stater, 22401
- Fredericksburg Oncology Inc
-
Richmond, Virginia, Forente stater, 23235
- VCU Massey Cancer Center at Stony Point
-
Richmond, Virginia, Forente stater, 23298
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Aberdeen, Washington, Forente stater, 98520
- Providence Regional Cancer System-Aberdeen
-
Anacortes, Washington, Forente stater, 98221
- Cancer Care Center at Island Hospital
-
Auburn, Washington, Forente stater, 98001
- MultiCare Auburn Medical Center
-
Bellevue, Washington, Forente stater, 98004
- Overlake Medical Center
-
Bellevue, Washington, Forente stater, 98005
- Swedish Cancer Institute-Eastside Oncology Hematology
-
Bellingham, Washington, Forente stater, 98225
- PeaceHealth Saint Joseph Medical Center
-
Centralia, Washington, Forente stater, 98531
- Providence Regional Cancer System-Centralia
-
Edmonds, Washington, Forente stater, 98026
- Swedish Cancer Institute-Edmonds
-
Everett, Washington, Forente stater, 98201
- Providence Regional Cancer Partnership
-
Gig Harbor, Washington, Forente stater, 98335
- MultiCare Gig Harbor Medical Park
-
Issaquah, Washington, Forente stater, 98029
- Swedish Cancer Institute-Issaquah
-
Kennewick, Washington, Forente stater, 99336
- Kadlec Clinic Hematology and Oncology
-
Lacey, Washington, Forente stater, 98503
- Providence Regional Cancer System-Lacey
-
Longview, Washington, Forente stater, 98632
- PeaceHealth Saint John Medical Center
-
Port Townsend, Washington, Forente stater, 98368
- Jefferson Healthcare
-
Puyallup, Washington, Forente stater, 98372
- MultiCare Good Samaritan Hospital
-
Renton, Washington, Forente stater, 98055
- Valley Medical Center
-
Seattle, Washington, Forente stater, 98107
- Swedish Medical Center-Ballard Campus
-
Seattle, Washington, Forente stater, 98122
- Swedish Medical Center-First Hill
-
Seattle, Washington, Forente stater, 98112
- Kaiser Permanente Washington
-
Seattle, Washington, Forente stater, 98104
- Minor and James Medical PLLC
-
Seattle, Washington, Forente stater, 98104
- Pacific Gynecology Specialists
-
Seattle, Washington, Forente stater, 98122-5711
- Swedish Medical Center-Cherry Hill
-
Sedro-Woolley, Washington, Forente stater, 98284
- PeaceHealth United General Medical Center
-
Shelton, Washington, Forente stater, 98584
- Providence Regional Cancer System-Shelton
-
Spokane, Washington, Forente stater, 99218
- Evergreen Hematology and Oncology PS
-
Spokane, Washington, Forente stater, 99204
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
-
Spokane, Washington, Forente stater, 99218
- MultiCare Deaconess Cancer and Blood Specialty Center - North
-
Spokane Valley, Washington, Forente stater, 99216
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
-
Tacoma, Washington, Forente stater, 98405
- Mary Bridge Children's Hospital and Health Center
-
Tacoma, Washington, Forente stater, 98405
- MultiCare Tacoma General Hospital
-
Vancouver, Washington, Forente stater, 98664
- PeaceHealth Southwest Medical Center
-
Walla Walla, Washington, Forente stater, 99362
- Providence Saint Mary Regional Cancer Center
-
Yakima, Washington, Forente stater, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
-
Yelm, Washington, Forente stater, 98597
- Providence Regional Cancer System-Yelm
-
-
Wisconsin
-
Eau Claire, Wisconsin, Forente stater, 54701
- Marshfield Medical Center-EC Cancer Center
-
Eau Claire, Wisconsin, Forente stater, 54701
- Marshfield Clinic Cancer Center at Sacred Heart
-
Green Bay, Wisconsin, Forente stater, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay, Wisconsin, Forente stater, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
La Crosse, Wisconsin, Forente stater, 54601
- Gundersen Lutheran Medical Center
-
Madison, Wisconsin, Forente stater, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Manitowoc, Wisconsin, Forente stater, 54221
- Holy Family Memorial Hospital
-
Marinette, Wisconsin, Forente stater, 54143
- Saint Vincent Hospital Cancer Center at Marinette
-
Marshfield, Wisconsin, Forente stater, 54449
- Marshfield Medical Center-Marshfield
-
Marshfield, Wisconsin, Forente stater, 54449
- Marshfield Medical Center
-
Milwaukee, Wisconsin, Forente stater, 53226
- Medical College of Wisconsin
-
Minocqua, Wisconsin, Forente stater, 54548
- Marshfield Medical Center - Minocqua
-
Oconto Falls, Wisconsin, Forente stater, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Rice Lake, Wisconsin, Forente stater, 54868
- Marshfield Medical Center-Rice Lake
-
Sheboygan, Wisconsin, Forente stater, 53081
- HSHS Saint Nicholas Hospital
-
Stevens Point, Wisconsin, Forente stater, 54482
- Marshfield Medical Center-River Region at Stevens Point
-
Sturgeon Bay, Wisconsin, Forente stater, 54235-1495
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
-
Wausau, Wisconsin, Forente stater, 54401
- Marshfield Clinic-Wausau Center
-
Weston, Wisconsin, Forente stater, 54476
- Marshfield Medical Center - Weston
-
-
Wyoming
-
Casper, Wyoming, Forente stater, 82609
- Rocky Mountain Oncology
-
Cheyenne, Wyoming, Forente stater, 82001
- Cheyenne Regional Medical Center-West
-
Cody, Wyoming, Forente stater, 82414
- Big Horn Basin Cancer Center
-
Cody, Wyoming, Forente stater, 82414
- Billings Clinic-Cody
-
Sheridan, Wyoming, Forente stater, 82801
- Welch Cancer Center
-
-
-
-
-
Haifa, Israel, 31096
- Rambam Medical Center
-
Jerusalem, Israel, 91031
- Shaare Zedek Medical Center
-
-
-
-
-
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
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Arm I (blinatumomab, chemotherapy)
See Detailed Description |
Given IV
Andre navn:
Given PO
Andre navn:
Undergo bone marrow biopsy
Andre navn:
Undergo blood sample collection
Andre navn:
Given IV
Andre navn:
Given IV
Andre navn:
Given IV
Andre navn:
Given PO
Andre navn:
Undergo allogeneic hematopoietic SCT
Andre navn:
Given IV
Andre navn:
Undergo bone marrow aspiration Given IT, IV, or SC
Andre navn:
Given IV
Andre navn:
Given IV
Andre navn:
Given IV
Andre navn:
Given IV or PO
Andre navn:
Undergo lumbar puncture
Andre navn:
Given PO
Andre navn:
Given PO, IT or IV
Andre navn:
Given IM or IV
Andre navn:
Undergo x-ray imaging
Andre navn:
|
|
Aktiv komparator: Arm II (chemotherapy)
See Detailed Description |
Given IV
Andre navn:
Given PO
Andre navn:
Undergo bone marrow biopsy
Andre navn:
Undergo blood sample collection
Andre navn:
Given IV
Andre navn:
Given IV
Andre navn:
Given IV
Andre navn:
Given PO
Andre navn:
Undergo allogeneic hematopoietic SCT
Andre navn:
Undergo bone marrow aspiration Given IT, IV, or SC
Andre navn:
Given IV
Andre navn:
Given IV
Andre navn:
Given IV
Andre navn:
Given IV or PO
Andre navn:
Undergo lumbar puncture
Andre navn:
Given PO
Andre navn:
Given PO, IT or IV
Andre navn:
Given IM or IV
Andre navn:
Undergo x-ray imaging
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
Resultatmål |
Tiltaksbeskrivelse |
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:
|
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:
|
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
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Mark R Litzow, ECOG-ACRIN Cancer Research Group
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Seftel MD. Hyper-CVAD: a regimen for all seasons. Lancet Haematol. 2020 Jul;7(7):e501-e502. doi: 10.1016/S2352-3026(20)30179-4. No abstract available.
- Litzow MR, Sun Z, Mattison RJ, Paietta EM, Roberts KG, Zhang Y, Racevskis J, Lazarus HM, Rowe JM, Arber DA, Wieduwilt MJ, Liedtke M, Bergeron J, Wood BL, Zhao Y, Wu G, Chang TC, Zhang W, Pratz KW, Dinner SN, Frey N, Gore SD, Bhatnagar B, Atallah EL, Uy GL, Jeyakumar D, Lin TL, Willman CL, DeAngelo DJ, Patel SB, Elliott MA, Advani AS, Tzachanis D, Vachhani P, Bhave RR, Sharon E, Little RF, Erba HP, Stone RM, Luger SM, Mullighan CG, Tallman MS. Blinatumomab for MRD-Negative Acute Lymphoblastic Leukemia in Adults. N Engl J Med. 2024 Jul 25;391(4):320-333. doi: 10.1056/NEJMoa2312948.
- Zhong X, Roberts KG, Wei H, Sun Z, Montefiori LE, Kumar A, Iacobucci I, Baviskar P, Gao Q, Polonen P, Pruett-Miller SM, Schreiber RM, Chang TC, Zhang W, Lei S, Rampersaud E, Fan Y, Wu G, Mattison RJ, Zhang Y, Racevskis J, Lazarus HM, Rowe JM, Arber DA, Wieduwilt MJ, Abou Mourad Y, Shami PJ, Baer MR, Asch AS, O'Dwyer KM, Hall A, Liedtke M, Bergeron J, Wood BL, Pratz KW, Dinner SN, Frey NV, Gore SD, Bhatnagar B, Atallah EL, Uy GL, Jeyakumar D, Lin TL, Willman CL, Podoltsev NA, DeAngelo DJ, Patel S, Elliott MA, Advani AS, Tzachanis D, Vachhani P, Bhave RR, Sharon E, Little RF, Erba HP, Stone RM, Tallman MS, Yang JJ, Luger SM, Paietta E, Litzow MR, Mullighan CG. Genomic drivers of leukemia and blinatumomab response in adult acute lymphoblastic leukemia - the ECOG-ACRIN E1910 study. Blood. 2026 Oct 5:blood.2026033793. doi: 10.1182/blood.2026033793. Online ahead of print.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Antatt)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Sykdommer i immunsystemet
- Infeksjoner
- Virussykdommer
- Neoplasmer etter histologisk type
- Hematologiske sykdommer
- DNA-virusinfeksjoner
- Lymfesykdommer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Lymfom, B-celle
- Lymfom
- Leukemi, lymfoid
- Leukemi
- Epstein-Barr-virusinfeksjoner
- Herpesviridae-infeksjoner
- Tumorvirusinfeksjoner
- Hemic og lymfatiske sykdommer
- Forløpercelle lymfoblastisk leukemi-lymfom
- Burkitt lymfom
- Aminosyrer, peptider og proteiner
- Proteiner
- Svovelforbindelser
- Organiske kjemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Undersøkelsesteknikker
- Terapeutikk
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Punkteringer
- Kirurgiske prosedyrer, operativ
- Cytologiske teknikker
- Nukleinsyrer, nukleotider og nukleosider
- Cytodiagnose
- Hydrokarboner
- Hydrokarboner, syklisk
- Karbohydrater
- Fysiske fenomener
- Alkaloider
- Podofyllotoksin
- Tetrahydronaftalener
- Naftalener
- Polysykliske aromatiske hydrokarboner
- Hydrokarboner, aromatisk
- Polysykliske forbindelser
- Glukosider
- Glykosider
- Transplantasjon
- Utstyr og forsyninger
- Enzymer og koenzymer
- Indoler
- Antistoffer, monoklonalt
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Puriner
- Cytidin
- Pyrimidin -nukleosider
- Pyrimidiner
- Gravadienes
- Gravaner
- Steroider
- Smeltede ringforbindelser
- Steroider, fluorert
- Benzenderivater
- Diagnostiske teknikker, kirurgisk
- Sulfonsyrer
- Svovelsyrer
- Fosforamid -sennep
- Nitrogen sennepsforbindelser
- Sennepsforbindelser
- Hydrokarboner, halogenert
- Fosforamider
- Organofosforforbindelser
- Nukleosider
- Formyltetrahydrofolater
- Tetrahydrofolater
- Folsyre
- Pteriner
- Pteridiner
- Gravadienetrioler
- Gravadienedioler
- Vinca -alkaloider
- Secologanin tryptaminalkaloider
- Indolalkaloider
- Indolizidiner
- Indolisiner
- Arabinonukleosider
- Aminopterin
- Antracykliner
- Naphthacenes
- Aminoglykosider
- Koenzymer
- Elektromagnetiske fenomener
- Magnetiske fenomener
- Antistoffer, monoklonale, murine-avledede
- Celletransplantasjon
- Celle- og vevsbasert terapi
- Biologisk terapi
- Diagnostiske teknikker, nevrologiske
- Elektromagnetisk stråling
- Stråling
- Stråling, ioniserende
- Benzenesulfonater
- Arylsulfonater
- Arylsulfonsyrer
- Sulfhydrylforbindelser
- Rituximab
- Deksametason
- Metotreksat
- Prednison
- Cyklofosfamid
- Cytarabin
- Etoposid
- Leucovorin
- Vincristine
- Daunorubicin
- Merkaptopurin
- Kalsiumdobesilat
- Biopsi
- Prøvehåndtering
- Blinatumomab
- Stamcelletransplantasjon
- Ryggraden
- Dexamethason 21-fosfat
- Røntgenbilder
- CT-P10
- Deltacortene
- Prednyliden
- N, N-Dicyclohexyl-Isoborneol-10-sulfonamid
- azathiopurine
- Merphos
- Pegaspargase
- Fantomer, avbildning
- auricularum
- Dexamethasonacetat
Andre studie-ID-numre
- NCI-2013-02229
- U10CA180820 (U.S. NIH-stipend/kontrakt)
- U24CA196172 (U.S. NIH-stipend/kontrakt)
- U10CA021115 (U.S. NIH-stipend/kontrakt)
- NCI-2013-02229 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- ECOG-E1910
- E1910 (Annen identifikator: CTEP)
- PE1910_A08PAMDREVW01
- E1910 (Annen identifikator: ECOG-ACRIN Cancer Research Group)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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