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Inotuzumab Ozogamicin og Blinatumomab til behandling af patienter med nyligt diagnosticeret, tilbagevendende eller refraktær CD22-positiv B-linje Akut lymfoblastisk leukæmi

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

Et fase II-studie af Inotuzumab Ozogamicin efterfulgt af Blinatumomab for Ph-negativ CD22-positiv B-linje Akut lymfoblastisk leukæmi hos nydiagnosticerede ældre voksne eller voksne med recidiverende eller refraktær sygdom

This phase II trial studies how well inotuzumab ozogamicin and blinatumomab with or without ponatinib work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back after a period of improvement (recurrent), or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug, called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving inotuzumab ozogamicin and blinatumomab with or without ponatinib may be effective in treating patients with newly diagnosed, recurrent or refractory CD22 positive B-lineage acute lymphoblastic leukemia.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

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 OBJECTIVES:

Ia. For Philadelphia (Ph)-negative B-cell acute lymphoblastic leukemia (ALL), to confirm tolerability of the combination regimen of inotuzumab ozogamicin followed by blinatumomab.

Ib. For Ph-positive B-cell ALL, to confirm tolerability of ponatinib in combination with inotuzumab ozogamicin and blinatumomab.

II. To estimate the 1-year event-free survival of older, transplant-ineligible patients with newly diagnosed, Ph-negative, CD22-positive, B-cell acute lymphoblastic leukemia (ALL) treated with inotuzumab ozogamicin induction followed by blinatumomab consolidation. (Cohort 1) III. To estimate the 1-year event-free survival of patients with relapsed or refractory Ph-negative, CD22-positive, B-cell ALL treated with inotuzumab ozogamicin induction followed by blinatumomab consolidation. (Cohort 2) IV. To determine the feasibility of the regimen in adult patients with CD22-positive, Ph/BCR-ABL1-positive B-cell ALL. (Cohort 3)

SECONDARY OBJECTIVES:

I. To estimate the median, 1-year, and 3-year overall survival (OS) in all eligible patients. (Cohort 1) II. To estimate the median, 1-year, and 3-year relapse-free survival (RFS) in all eligible patients. (Cohort 1) III. To estimate the median and 3-year event-free survival (EFS) in all eligible patients. (Cohort 1) IV. To estimate the complete response (CR) rate and overall response rate (ORR, defined as complete response [CR] + complete response with incomplete count recovery [CRi]) to inotuzumab ozogamicin followed by blinatumomab (regimen CR rate and ORR). (Cohort 1) V. To estimate the CR rate and ORR (CR + CRi) to inotuzumab ozogamicin induction alone (induction CR and ORR). (Cohort 1) VI. To estimate the minimal residual disease (MRD) negativity rate in subjects achieving a CR or CRi. (Cohort 1) VII. To estimate the treatment-related mortality with this regimen. (Cohort 1) VIII. To describe the safety and tolerability of this regimen. (Cohort 1) IX. To estimate the median, 1-year, and 3-year OS in all eligible patients. (Cohort 2) X. To estimate the median, 1-year, and 3-year RFS in all eligible patients. (Cohort 2) XI. To estimate the median and 3-year EFS in all eligible patients. (Cohort 2) XII. To estimate ORR (CR/CRi and CR/complete response with partial hematologic recovery [CRh]) to blinatumomab in patients with ALL refractory to inotuzumab ozogamicin. (Cohort 2) XIII. To estimate the CR, CRi, and CRh rates at defined time points and cumulatively for the entire regimen. (Cohort 2) XIV. To determine the MRD negativity (< 10^-4) rate at defined time points including prior to allogeneic HCT and cumulatively in patients achieving a CR, CRh, or CRi. (Cohort 2) XV. To determine the allogeneic hematopoietic cell transplantation (HCT) rate in eligible subjects. (Cohort 2) XVI. To estimate the treatment-related mortality with this regimen. (Cohort 2) XVII. To describe the safety and tolerability of this regimen. (Cohort 2) XVIII. To estimate the 24-week complete molecular response rate. (Cohort 3) XIX. To estimate the median, 1-year, and 3-year OS in all eligible patients. (Cohort 3) XX. To estimate the median, 1-year, and 3-year RFS in all eligible patients. (Cohort 3) XXI. To estimate the median and 3-year EFS in all eligible patients. (Cohort 3) XXII. To estimate ORR (CR/CRi and CR/complete response with partial hematologic recovery [CRh]) to blinatumomab in patients with ALL refractory to inotuzumab ozogamicin. (Cohort 3) XXIII. To estimate the CR, CRi, and CRh rates at defined time points and cumulatively for the entire regimen. (Cohort 3) XXIV. To determine the complete molecular response rate at defined time points and cumulatively in patients achieving a CR, CRh, or CRi. (Cohort 3) XXV. To estimate the treatment-related mortality with this regimen. (Cohort 3) XXVI. To describe the safety and tolerability of this regimen. (Cohort 3)

OTHER OBJECTIVE:

I. Results of the primary analysis will be examined for consistency, while accounting for the stratification factors and/or covariates of baseline quality of life (QOL) and fatigue.

CORRELATIVE SCIENCE OBJECTIVES:

I. To correlate specific karyotype groups (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters.

II. To correlate specific karyotype groups with response rates, response duration, survival, and cure in patients treated with inotuzumab ozogamicin followed by blinatumomab.

III. To correlate specific karyotype groups with MRD. IV. To determine karyotype changes at relapse and the influence of the type of change (or no change) in karyotype at relapse.

V. To assess the correlation of quantitative MRD post-induction with inotuzumab ozogamicin and at sequential consolidation time points with blinatumomab with RFS, EFS, and OS.

VI. To correlate the influence of MRD status (detectable versus [vs.] not and as a continuous measure) in relation to EFS, RFS, and OS with other clinical and biological factors (e.g. previously untreated vs. relapsed disease cohorts; age, initial white blood cell [WBC] count, cytogenetics).

VII. To identify genetic variants and predictors of ex vivo resistance. VIII. To identify genetic variants and predictors of MRD. IX. To identify genetic variants and predictors of relapse. X. To determine inter-patient variability in drug sensitivity of adult ALL. XI. To examine the associations of drug sensitivity with host and leukemia molecular features.

XII. To evaluate T-cell populations and T-cell function during therapy using T-cell markers which include the T-cell subset defining markers CD45, CD3, CD4, CD8, CD45RA, CD45RO, CCR7, CD25, CD127, FOXP3, CD 27, CD28, among others, and markers of T cell exhaustion and senescence including CD57, PD-1, Tim-3, LAG-3, TIGIT, CTLA4, CD160, and ICOS among others.

XIII. To evaluate cytokine levels, and compare between patients who attain a CR vs. those with stable or progressive disease.

EXPLORATORY OBJECTIVES:

I. To estimate the median, 1-year, and 3-year RFS, EFS, and OS in patients achieving a CR/CRi to inotuzumab ozogamicin. (Cohort 1) II. To compare the median, 1-year, and 3-year RFS, EFS, and OS among patients achieving MRD-negative vs. MRD-positive CR/CRi to inotuzumab ozogamicin. (Cohort 1) III. To compare the median, 1-year, and 3-year RFS, EFS, and OS among patients achieving MRD-negative vs. MRD-positive CR/CRi at any time. (Cohort 1) IV. To describe the rate, severity, and timing of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver after limited inotuzumab ozogamicin exposure and identify risk factors for SOS/VOD. (Cohort 1) V. To estimate the rate of cytokine release syndrome in this population. (Cohort 1) VI. To estimate the median, 1-year, and 3-year RFS from time of CR/CRi to inotuzumab ozogamicin in patients receiving inotuzumab ozogamicin followed by blinatumomab and not undergoing allogeneic hematopoietic cell transplantation (HCT). (Cohort 2) VII. To estimate median, 1-year, and 3-year OS after CR/CRi to inotuzumab ozogamicin in patients not undergoing allogeneic HCT. (Cohort 2) VIII. To compare in a non-randomized fashion median, 1-year, and 3-year OS, median, 1-year, and 3-year RFS, cumulative incidence of relapse (CIR), and non-relapse mortality (NRM) between patients achieving CR/CRi and receiving consolidation with or without allogeneic HCT. (Cohort 2) IX. To describe the rate, severity, and timing of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver after limited inotuzumab ozogamicin exposure and identify risk factors for SOS/VOD. (Cohort 2) X. To estimate the rate of cytokine release syndrome in this population. (Cohort 2) XI. To estimate the median, 1-year, and 3-year RFS, EFS, and OS in patients achieving a CR/CRi to inotuzumab ozogamicin. (Cohort 3) XII. To compare the median, 1-year, and 3-year RFS, EFS, and OS among patients with CR/CRi achieving complete molecular response vs. not to inotuzumab ozogamicin. (Cohort 3) XIII. To compare the median, 1-year, and 3-year RFS, EFS, and OS among patients achieving CR/CRi achieving complete molecular response vs. not at any time. (Cohort 3) XIV. To describe the rate, severity, and timing of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver after limited inotuzumab ozogamicin exposure and identify risk factors for SOS/VOD. (Cohort 3) XV. To estimate the rate of cytokine release syndrome in this population. (Cohort 3) XVI. To assess ABL1 mutational patterns at relapse. (Cohort 3)

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT 1: Patients receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day 1, 8, and 15 (Course IA). By the end of Course IA (day 21), patients with adequate ALL cytoreduction continue to Course IB/IC, and patients who fail to achieve ALL cytoreduction continue to Course II. By the end of Course II, patients with CR-CRi to Course IB/IC and Course II continue to Course IIIA, patients without adequate ALL cytoreduction to Course IA or refractory to Course IB/IC but CR/CRi to Course II continue to Course IIIB. Patients undergo bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients undergo lumbar puncture with cerebrospinal fluid sample collection at baseline and may undergo additionally throughout the study.

COHORT 2: Patients receive inotuzumab ozogamicin IV over 1 hour on day 1, 8, and 15 (Course IA). By the end of Course IA (day 21), patients with adequate ALL cytoreduction continue to Course IB/IC, and patients who fail to achieve ALL cytoreduction continue to Course II. Patients with CR/CRi at the end of Course II continue to Course IIIB.

COURSE IB/IC: Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Treatment continues for 1 course (28 days) in the absence of disease progression or unacceptable toxicity.

COURSE II: Patients receive blinatumomab IV continuously on days 1-28 and 43-70. Treatment continues for 1 course (84 days) in the absence of disease progression or unacceptable toxicity.

COURSE IIIA: Patients receive blinatumomab IV continuously on days 1-28 and 43-70. Treatment continues for 1 course (84 days) in the absence of disease progression or unacceptable toxicity.

COURSE IIIB: Patients receive blinatumomab IV continuously on days 1-28, 43-70, and 85-112. Treatment continues for 1 course (126 days) in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients undergo lumbar puncture with cerebrospinal fluid sample collection at baseline and may undergo additionally throughout the study.

COHORT 3:

INDUCTION:

COURSE I: Patients receive ponatinib orally (PO) daily (QD) on day 1-35, dexamethasone PO QD on days 1-7 and 15-21 and methotrexate intrathecally (IT) on day 1, 15 and 29 for 1 course (35 days) in the absence of disease progression or unacceptable toxicity. Patients with CR or CRi continue to consolidation course IIA or end the study treatment to receive allogenic HCT per the treating physician. Patients without CR or CRi with but adequate ALL cytoreduction (defined as ≥ 50% reduction in bone marrow lymphoblasts from the pre-registration bone marrow aspirate/biopsy and/or ≤ 20% marrow cellularity at the end of Course I bone marrow aspirate/biopsy) also proceed to consolidation course IIA. Patients with progression or failure to achieve adequate ALL cytoreduction are removed from study treatment.

CONSOLIDATION:

COURSE IIA: Patients receive ponatinib PO QD on days 1-21, inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 and methotrexate IT on day 1 for 1 course (21 days) in the absence of disease progression or unacceptable toxicity. Patients with CR or CRi continue to consolidation course IIB or end the study treatment to receive allogenic HCT per the treating physician. Patients without CR or CRi and without progressive disease proceed to course IIC. Patients with progression are removed from study treatment.

COURSE IIB/C: Patients receive ponatinib PO QD on days 1-28, inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 and methotrexate IT on day 1 for 1 course (28 days) in the absence of disease progression or unacceptable toxicity. Patients with CR or CRi end the study treatment to receive allogenic HCT per the treating physician. Patients with progression are removed from study treatment. All other patients proceed to course III.

COURSE III: Patients receive ponatinib PO QD on days 1-84 and receive blinatumomab IV continuously on days 1-28 and 43-70. Treatment continues for 1 course (84 days) in the absence of disease progression or unacceptable toxicity. Patients in CR/CRi proceed to course IV. Patients not in CR/CRi are removed from study treatment.

COURSE IV: Patients receive ponatinib PO QD on days 1-84 and receive blinatumomab IV continuously on days 1-28 and 43-70. Treatment continues for 1 course (84 days) in the absence of disease progression or unacceptable toxicity. Patients in CR/CRi proceed to maintenance. Patients not in CR/CRi are removed from study treatment.

MAINTENANCE: Patients receive ponatinib PO QD for 24 months in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients undergo lumbar puncture with cerebrospinal fluid sample collection at baseline and may undergo additionally throughout the study.

After completion of study treatment, patients are followed up every 3 months for 3 years, and then every 6 months for up to 10 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 (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
84

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 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • Aktiv, ikke rekrutterende
        • University of Alabama at Birmingham Cancer Center
    • Alaska
      • Anchorage, Alaska, Forenede Stater, 98508
        • Suspenderet
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, Forenede Stater, 99504
        • Suspenderet
        • Anchorage Radiation Therapy Center
      • Anchorage, Alaska, Forenede Stater, 99508
        • Suspenderet
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, Forenede Stater, 99508
        • Suspenderet
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, Forenede Stater, 99508
        • Suspenderet
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, Forenede Stater, 99508
        • Suspenderet
        • Anchorage Oncology Centre
      • Anchorage, Alaska, Forenede Stater, 99508
        • Suspenderet
        • Katmai Oncology Group
      • Anchorage, Alaska, Forenede Stater, 99508
        • Suspenderet
        • Providence Alaska Medical Center
    • Arizona
      • Kingman, Arizona, Forenede Stater, 86401
        • Suspenderet
        • Kingman Regional Medical Center
    • Arkansas
      • Fort Smith, Arkansas, Forenede Stater, 72903
        • Suspenderet
        • Mercy Hospital Fort Smith
    • California
      • Arroyo Grande, California, Forenede Stater, 93420
        • Suspenderet
        • PCR Oncology
      • Burbank, California, Forenede Stater, 91505
        • Suspenderet
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Clovis, California, Forenede Stater, 93611
        • Aktiv, ikke rekrutterende
        • Community Cancer Institute
      • Clovis, California, Forenede Stater, 93611
        • Aktiv, ikke rekrutterende
        • University Oncology Associates
      • Duarte, California, Forenede Stater, 91010
        • Rekruttering
        • City of Hope Comprehensive Cancer Center
        • Kontakt:
        • Ledende efterforsker:
          • Ibrahim Aldoss
      • Irvine, California, Forenede Stater, 92612
        • Rekruttering
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
        • Ledende efterforsker:
          • Deepa Jeyakumar
        • Kontakt:
      • La Jolla, California, Forenede Stater, 92093
        • Rekruttering
        • UC San Diego Moores Cancer Center
        • Ledende efterforsker:
          • James K. Mangan
        • Kontakt:
      • Orange, California, Forenede Stater, 92868
        • Rekruttering
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Ledende efterforsker:
          • Deepa Jeyakumar
        • Kontakt:
      • Palo Alto, California, Forenede Stater, 94304
        • Aktiv, ikke rekrutterende
        • Stanford Cancer Institute Palo Alto
    • Delaware
      • Lewes, Delaware, Forenede Stater, 19958
        • Suspenderet
        • Beebe Medical Center
      • Millville, Delaware, Forenede Stater, 19967
        • Suspenderet
        • Beebe South Coastal Health Campus
      • Newark, Delaware, Forenede Stater, 19713
        • Rekruttering
        • Helen F Graham Cancer Center
        • Ledende efterforsker:
          • Gregory A. Masters
        • Kontakt:
      • Newark, Delaware, Forenede Stater, 19713
        • Suspenderet
        • Delaware Clinical and Laboratory Physicians PA
      • Newark, Delaware, Forenede Stater, 19713
        • Rekruttering
        • Medical Oncology Hematology Consultants PA
        • Ledende efterforsker:
          • Gregory A. Masters
        • Kontakt:
      • Newark, Delaware, Forenede Stater, 19718
        • Suspenderet
        • Christiana Care Health System-Christiana Hospital
      • Rehoboth Beach, Delaware, Forenede Stater, 19971
        • Suspenderet
        • Beebe Health Campus
      • Seaford, Delaware, Forenede Stater, 19973
        • Suspenderet
        • TidalHealth Nanticoke / Allen Cancer Center
      • Wilmington, Delaware, Forenede Stater, 19801
        • Suspenderet
        • Christiana Care Health System-Wilmington Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20007
        • Rekruttering
        • MedStar Georgetown University Hospital
        • Ledende efterforsker:
          • Kimberley Doucette
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 202-444-2223
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33308
        • Suspenderet
        • Holy Cross Hospital
      • Jupiter, Florida, Forenede Stater, 33458
        • Rekruttering
        • Jupiter Medical Center
        • Ledende efterforsker:
          • Ryan H. Devine
        • Kontakt:
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Rekruttering
        • Emory University Hospital/Winship Cancer Institute
        • Ledende efterforsker:
          • William G. Blum
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 404-778-1868
      • Atlanta, Georgia, Forenede Stater, 30342
        • Rekruttering
        • Emory Saint Joseph's Hospital
        • Ledende efterforsker:
          • William G. Blum
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 404-851-7115
    • Idaho
      • Boise, Idaho, Forenede Stater, 83712
        • Suspenderet
        • Saint Luke's Cancer Institute - Boise
      • Fruitland, Idaho, Forenede Stater, 83619
        • Suspenderet
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, Forenede Stater, 83642
        • Suspenderet
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, Forenede Stater, 83687
        • Rekruttering
        • Saint Alphonsus Cancer Care Center-Nampa
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Nampa, Idaho, Forenede Stater, 83687
        • Suspenderet
        • Saint Luke's Cancer Institute - Nampa
      • Twin Falls, Idaho, Forenede Stater, 83301
        • Suspenderet
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Alton, Illinois, Forenede Stater, 62002
        • Suspenderet
        • OSF Saint Anthony's Health Center
      • Bloomington, Illinois, Forenede Stater, 61704
        • Suspenderet
        • Illinois CancerCare-Bloomington
      • Burr Ridge, Illinois, Forenede Stater, 60527
        • Suspenderet
        • Loyola Center for Health at Burr Ridge
      • Canton, Illinois, Forenede Stater, 61520
        • Suspenderet
        • Illinois CancerCare-Canton
      • Carbondale, Illinois, Forenede Stater, 62902
        • Suspenderet
        • Memorial Hospital of Carbondale
      • Carterville, Illinois, Forenede Stater, 62918
        • Suspenderet
        • SIH Cancer Institute
      • Carthage, Illinois, Forenede Stater, 62321
        • Suspenderet
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, Forenede Stater, 62801
        • Suspenderet
        • Centralia Oncology Clinic
      • Chicago, Illinois, Forenede Stater, 60637
        • Rekruttering
        • University of Chicago Comprehensive Cancer Center
        • Ledende efterforsker:
          • Wendy Stock
        • Kontakt:
      • Chicago, Illinois, Forenede Stater, 60611
        • Rekruttering
        • Northwestern University
        • Ledende efterforsker:
          • Shira N. Dinner
        • Kontakt:
      • Chicago, Illinois, Forenede Stater, 60612
        • Rekruttering
        • University of Illinois
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 312-355-3046
        • Ledende efterforsker:
          • John G. Quigley
      • Decatur, Illinois, Forenede Stater, 62526
        • Rekruttering
        • Cancer Care Specialists of Illinois - Decatur
        • Ledende efterforsker:
          • Bryan A. Faller
        • Kontakt:
      • Decatur, Illinois, Forenede Stater, 62526
        • Suspenderet
        • Decatur Memorial Hospital
      • Dixon, Illinois, Forenede Stater, 61021
        • Suspenderet
        • Illinois CancerCare-Dixon
      • Effingham, Illinois, Forenede Stater, 62401
        • Rekruttering
        • Crossroads Cancer Center
        • Ledende efterforsker:
          • Bryan A. Faller
        • Kontakt:
      • Eureka, Illinois, Forenede Stater, 61530
        • Suspenderet
        • Illinois CancerCare-Eureka
      • Evanston, Illinois, Forenede Stater, 60201
        • Rekruttering
        • NorthShore University HealthSystem-Evanston Hospital
        • Ledende efterforsker:
          • Amy Y. Wang
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 847-570-2109
      • Galesburg, Illinois, Forenede Stater, 61401
        • Suspenderet
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, Forenede Stater, 61401
        • Suspenderet
        • Illinois CancerCare-Galesburg
      • Glenview, Illinois, Forenede Stater, 60026
        • Rekruttering
        • NorthShore University HealthSystem-Glenbrook Hospital
        • Ledende efterforsker:
          • Amy Y. Wang
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 847-570-2109
      • Highland Park, Illinois, Forenede Stater, 60035
        • Rekruttering
        • NorthShore University HealthSystem-Highland Park Hospital
        • Ledende efterforsker:
          • Amy Y. Wang
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 847-570-2109
      • Homer Glen, Illinois, Forenede Stater, 60491
        • Suspenderet
        • Loyola Medicine Homer Glen
      • Kewanee, Illinois, Forenede Stater, 61443
        • Suspenderet
        • Illinois CancerCare-Kewanee Clinic
      • Lake Forest, Illinois, Forenede Stater, 60045
        • Aktiv, ikke rekrutterende
        • Northwestern Medicine Lake Forest Hospital
      • Macomb, Illinois, Forenede Stater, 61455
        • Suspenderet
        • Illinois CancerCare-Macomb
      • Maywood, Illinois, Forenede Stater, 60153
        • Rekruttering
        • Loyola University Medical Center
        • Ledende efterforsker:
          • Stephanie B. Tsai
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 708-226-4357
      • Melrose Park, Illinois, Forenede Stater, 60160
        • Suspenderet
        • Marjorie Weinberg Cancer Center at Loyola-Gottlieb
      • Mount Vernon, Illinois, Forenede Stater, 62864
        • Suspenderet
        • SSM Health Good Samaritan
      • New Lenox, Illinois, Forenede Stater, 60451
        • Rekruttering
        • UC Comprehensive Cancer Center at Silver Cross
        • Ledende efterforsker:
          • Wendy Stock
        • Kontakt:
      • O'Fallon, Illinois, Forenede Stater, 62269
        • Suspenderet
        • Cancer Care Center of O'Fallon
      • Orland Park, Illinois, Forenede Stater, 60462
        • Rekruttering
        • University of Chicago Medicine-Orland Park
        • Ledende efterforsker:
          • Wendy Stock
        • Kontakt:
      • Ottawa, Illinois, Forenede Stater, 61350
        • Suspenderet
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, Forenede Stater, 61554
        • Suspenderet
        • Illinois CancerCare-Pekin
      • Pekin, Illinois, Forenede Stater, 61554
        • Suspenderet
        • OSF Saint Francis Radiation Oncology at Pekin
      • Peoria, Illinois, Forenede Stater, 61615
        • Rekruttering
        • Illinois CancerCare-Peoria
        • Kontakt:
        • Ledende efterforsker:
          • Bryan A. Faller
      • Peoria, Illinois, Forenede Stater, 61636
        • Suspenderet
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Forenede Stater, 61615
        • Suspenderet
        • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
      • Peoria, Illinois, Forenede Stater, 61637
        • Suspenderet
        • OSF Saint Francis Medical Center
      • Peru, Illinois, Forenede Stater, 61354
        • Suspenderet
        • Valley Radiation Oncology
      • Peru, Illinois, Forenede Stater, 61354
        • Suspenderet
        • Illinois CancerCare-Peru
      • Princeton, Illinois, Forenede Stater, 61356
        • Suspenderet
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, Forenede Stater, 62702
        • Suspenderet
        • Springfield Clinic
      • Springfield, Illinois, Forenede Stater, 62702
        • Suspenderet
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, Forenede Stater, 62781
        • Suspenderet
        • Springfield Memorial Hospital
      • Washington, Illinois, Forenede Stater, 61571
        • Suspenderet
        • Illinois CancerCare - Washington
    • Iowa
      • Ankeny, Iowa, Forenede Stater, 50023
        • Rekruttering
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 515-241-3305
        • Ledende efterforsker:
          • Seema Harichand-Herdt
      • Clive, Iowa, Forenede Stater, 50325
        • Rekruttering
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 515-241-3305
        • Ledende efterforsker:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Forenede Stater, 50309
        • Rekruttering
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 515-241-3305
        • Ledende efterforsker:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Forenede Stater, 50314
        • Rekruttering
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 515-241-3305
        • Ledende efterforsker:
          • Seema Harichand-Herdt
      • Waukee, Iowa, Forenede Stater, 50263
        • Rekruttering
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 515-241-3305
        • Ledende efterforsker:
          • Seema Harichand-Herdt
    • Kansas
      • Garden City, Kansas, Forenede Stater, 67846
        • Suspenderet
        • Central Care Cancer Center - Garden City
      • Great Bend, Kansas, Forenede Stater, 67530
        • Suspenderet
        • Central Care Cancer Center - Great Bend
      • Kansas City, Kansas, Forenede Stater, 66160
        • Rekruttering
        • University of Kansas Cancer Center
        • Ledende efterforsker:
          • Kenneth Byrd
        • Kontakt:
      • Westwood, Kansas, Forenede Stater, 66205
        • Rekruttering
        • University of Kansas Hospital-Westwood Cancer Center
        • Ledende efterforsker:
          • Kenneth Byrd
        • Kontakt:
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Aktiv, ikke rekrutterende
        • Ochsner Medical Center Jefferson
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • Aktiv, ikke rekrutterende
        • University of Maryland/Greenebaum Cancer Center
    • Massachusetts
      • Springfield, Massachusetts, Forenede Stater, 01104
        • Aktiv, ikke rekrutterende
        • Mercy Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • Rekruttering
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Brighton, Michigan, Forenede Stater, 48114
        • Rekruttering
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Brighton, Michigan, Forenede Stater, 48114
        • Rekruttering
        • Trinity Health Medical Center - Brighton
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Canton, Michigan, Forenede Stater, 48188
        • Rekruttering
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Canton, Michigan, Forenede Stater, 48188
        • Rekruttering
        • Trinity Health Medical Center - Canton
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Caro, Michigan, Forenede Stater, 48723
        • Suspenderet
        • Caro Cancer Center
      • Chelsea, Michigan, Forenede Stater, 48118
        • Rekruttering
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Chelsea, Michigan, Forenede Stater, 48118
      • Clarkston, Michigan, Forenede Stater, 48346
        • Suspenderet
        • Hematology Oncology Consultants-Clarkston
      • Clarkston, Michigan, Forenede Stater, 48346
        • Suspenderet
        • Newland Medical Associates-Clarkston
      • Detroit, Michigan, Forenede Stater, 48236
        • Rekruttering
        • Henry Ford Health Saint John Hospital
        • Ledende efterforsker:
          • Christopher M. Reynolds
        • Kontakt:
      • East China Township, Michigan, Forenede Stater, 48054
        • Rekruttering
        • Henry Ford River District Hospital
        • Ledende efterforsker:
          • Christopher M. Reynolds
        • Kontakt:
      • Flint, Michigan, Forenede Stater, 48503
        • Rekruttering
        • Genesys Hurley Cancer Institute
        • Ledende efterforsker:
          • Christopher M. Reynolds
        • Kontakt:
      • Flint, Michigan, Forenede Stater, 48503
        • Rekruttering
        • Hurley Medical Center
        • Ledende efterforsker:
          • Christopher M. Reynolds
        • Kontakt:
      • Flint, Michigan, Forenede Stater, 48503
        • Suspenderet
        • Genesee Hematology Oncology PC
      • Flint, Michigan, Forenede Stater, 48503
        • Rekruttering
        • Cancer Hematology Centers - Flint
        • Ledende efterforsker:
          • Christopher M. Reynolds
        • Kontakt:
      • Grosse Pointe Woods, Michigan, Forenede Stater, 48236
        • Suspenderet
        • Henry Ford Saint John Hospital - Breast
      • Grosse Pointe Woods, Michigan, Forenede Stater, 48236
        • Rekruttering
        • Henry Ford Saint John Hospital - Academic
        • Ledende efterforsker:
          • Christopher M. Reynolds
        • Kontakt:
      • Grosse Pointe Woods, Michigan, Forenede Stater, 48236
        • Rekruttering
        • Henry Ford Saint John Hospital - Van Elslander
        • Ledende efterforsker:
          • Christopher M. Reynolds
        • Kontakt:
      • Lansing, Michigan, Forenede Stater, 48912
        • Suspenderet
        • University of Michigan Health - Sparrow Lansing
      • Livonia, Michigan, Forenede Stater, 48154
        • Suspenderet
        • Hope Cancer Clinic
      • Livonia, Michigan, Forenede Stater, 48154
        • Rekruttering
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Macomb, Michigan, Forenede Stater, 48044
        • Suspenderet
        • Henry Ford Warren Hospital - Breast Macomb
      • Macomb, Michigan, Forenede Stater, 48044
        • Rekruttering
        • Henry Ford Saint John Hospital - Macomb Medical
        • Ledende efterforsker:
          • Christopher M. Reynolds
        • Kontakt:
      • Marlette, Michigan, Forenede Stater, 48453
        • Suspenderet
        • Saint Mary's Oncology/Hematology Associates of Marlette
      • Pontiac, Michigan, Forenede Stater, 48341
        • Suspenderet
        • Hope Cancer Center
      • Pontiac, Michigan, Forenede Stater, 48341
        • Rekruttering
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Pontiac, Michigan, Forenede Stater, 48341
        • Suspenderet
        • Michigan Healthcare Professionals Pontiac
      • Pontiac, Michigan, Forenede Stater, 48341
        • Suspenderet
        • Trinity Health IHA Medical Group-Alice Gustafson Center
      • Rochester Hills, Michigan, Forenede Stater, 48309
        • Suspenderet
        • Henry Ford Rochester Hospital
      • Saginaw, Michigan, Forenede Stater, 48604
        • Suspenderet
        • Oncology Hematology Associates of Saginaw Valley PC
      • Saginaw, Michigan, Forenede Stater, 48601
        • Rekruttering
        • MyMichigan Medical Center Saginaw
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Sterling Heights, Michigan, Forenede Stater, 48312
        • Suspenderet
        • Bhadresh Nayak MD PC-Sterling Heights
      • Tawas City, Michigan, Forenede Stater, 48764
        • Rekruttering
        • MyMichigan Medical Center Tawas
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Warren, Michigan, Forenede Stater, 48088
        • Suspenderet
        • Advanced Breast Care Center PLLC
      • Warren, Michigan, Forenede Stater, 48093
        • Suspenderet
        • Macomb Hematology Oncology PC
      • Warren, Michigan, Forenede Stater, 48093
        • Suspenderet
        • Henry Ford Madison Heights Hospital - Breast
      • Warren, Michigan, Forenede Stater, 48093
        • Rekruttering
        • Henry Ford Health Warren Hospital
        • Ledende efterforsker:
          • Christopher M. Reynolds
        • Kontakt:
      • Warren, Michigan, Forenede Stater, 48093
        • Rekruttering
        • Henry Ford Warren Hospital - GLCMS
        • Ledende efterforsker:
          • Christopher M. Reynolds
        • Kontakt:
      • West Branch, Michigan, Forenede Stater, 48661
        • Suspenderet
        • Saint Mary's Oncology/Hematology Associates of West Branch
      • Ypsilanti, Michigan, Forenede Stater, 48106
      • Ypsilanti, Michigan, Forenede Stater, 48197
        • Rekruttering
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Afsluttet
        • Mayo Clinic in Rochester
    • Missouri
      • Ballwin, Missouri, Forenede Stater, 63011
        • Suspenderet
        • Mercy Oncology and Hematology - Clayton-Clarkson
      • Bolivar, Missouri, Forenede Stater, 65613
        • Suspenderet
        • Central Care Cancer Center - Bolivar
      • Branson, Missouri, Forenede Stater, 65616
        • Suspenderet
        • Cox Cancer Center Branson
      • Cape Girardeau, Missouri, Forenede Stater, 63703
        • Suspenderet
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, Forenede Stater, 63703
        • Suspenderet
        • Mercy Cancer Center - Cape Girardeau
      • City of Saint Peters, Missouri, Forenede Stater, 63376
        • Rekruttering
        • Siteman Cancer Center at Saint Peters Hospital
        • Ledende efterforsker:
          • Geoffrey L. Uy
        • Kontakt:
      • Creve Coeur, Missouri, Forenede Stater, 63141
        • Rekruttering
        • Siteman Cancer Center at West County Hospital
        • Ledende efterforsker:
          • Geoffrey L. Uy
        • Kontakt:
      • Farmington, Missouri, Forenede Stater, 63640
        • Suspenderet
        • Parkland Health Center - Farmington
      • Jefferson City, Missouri, Forenede Stater, 65109
        • Suspenderet
        • MU Health Care Goldschmidt Cancer Center
      • Joplin, Missouri, Forenede Stater, 64804
        • Suspenderet
        • Freeman Health System
      • Joplin, Missouri, Forenede Stater, 64804
        • Suspenderet
        • Mercy Hospital Joplin
      • Rolla, Missouri, Forenede Stater, 65401
        • Suspenderet
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, Forenede Stater, 65401
        • Suspenderet
        • Phelps Health Delbert Day Cancer Institute
      • Saint Joseph, Missouri, Forenede Stater, 64506
        • Suspenderet
        • Heartland Regional Medical Center
      • Sainte Genevieve, Missouri, Forenede Stater, 63670
        • Suspenderet
        • Sainte Genevieve County Memorial Hospital
      • Springfield, Missouri, Forenede Stater, 65804
        • Suspenderet
        • Mercy Hospital Springfield
      • Springfield, Missouri, Forenede Stater, 65807
        • Suspenderet
        • CoxHealth South Hospital
      • St Louis, Missouri, Forenede Stater, 63110
        • Rekruttering
        • Washington University School of Medicine
        • Ledende efterforsker:
          • Geoffrey L. Uy
        • Kontakt:
      • St Louis, Missouri, Forenede Stater, 63128
        • Rekruttering
        • Mercy Hospital South
        • Ledende efterforsker:
          • Jay W. Carlson
        • Kontakt:
      • St Louis, Missouri, Forenede Stater, 63141
        • Rekruttering
        • Mercy Hospital Saint Louis
        • Ledende efterforsker:
          • Jay W. Carlson
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 314-251-7066
      • St Louis, Missouri, Forenede Stater, 63129
        • Rekruttering
        • Siteman Cancer Center-South County
        • Ledende efterforsker:
          • Geoffrey L. Uy
        • Kontakt:
      • St Louis, Missouri, Forenede Stater, 63136
        • Rekruttering
        • Siteman Cancer Center at Christian Hospital
        • Ledende efterforsker:
          • Geoffrey L. Uy
        • Kontakt:
      • St Louis, Missouri, Forenede Stater, 63109
        • Suspenderet
        • Mercy Infusion Center - Chippewa
      • St Louis, Missouri, Forenede Stater, 63131
        • Suspenderet
        • Missouri Baptist Medical Center
      • Sullivan, Missouri, Forenede Stater, 63080
        • Suspenderet
        • Missouri Baptist Sullivan Hospital
      • Washington, Missouri, Forenede Stater, 63090
        • Suspenderet
        • Mercy Hospital Washington
    • Montana
      • Missoula, Montana, Forenede Stater, 59802
        • Suspenderet
        • Saint Patrick Hospital - Community Hospital
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68198
        • Aktiv, ikke rekrutterende
        • University of Nebraska Medical Center
      • Omaha, Nebraska, Forenede Stater, 68118
        • Aktiv, ikke rekrutterende
        • Nebraska Medicine-Village Pointe
    • Nevada
      • Carson City, Nevada, Forenede Stater, 89703
        • Suspenderet
        • Carson Tahoe Regional Medical Center
      • Henderson, Nevada, Forenede Stater, 89052
        • Suspenderet
        • Cancer and Blood Specialists-Henderson
      • Henderson, Nevada, Forenede Stater, 89052
        • Suspenderet
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson, Nevada, Forenede Stater, 89052
        • Suspenderet
        • Comprehensive Cancer Centers of Nevada-Horizon Ridge
      • Henderson, Nevada, Forenede Stater, 89052
        • Suspenderet
        • Las Vegas Cancer Center-Henderson
      • Henderson, Nevada, Forenede Stater, 89074
        • Suspenderet
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
      • Henderson, Nevada, Forenede Stater, 89074
        • Suspenderet
        • Las Vegas Urology - Green Valley
      • Henderson, Nevada, Forenede Stater, 89074
        • Suspenderet
        • Las Vegas Urology - Pebble
      • Henderson, Nevada, Forenede Stater, 89074
        • Suspenderet
        • Urology Specialists of Nevada - Green Valley
      • Henderson, Nevada, Forenede Stater, 89074
        • Suspenderet
        • Oncology Las Vegas - Henderson
      • Las Vegas, Nevada, Forenede Stater, 89102
        • Suspenderet
        • Desert West Surgery
      • Las Vegas, Nevada, Forenede Stater, 89109
        • Suspenderet
        • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
      • Las Vegas, Nevada, Forenede Stater, 89113
        • Suspenderet
        • HealthCare Partners Medical Group Oncology/Hematology-San Martin
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Suspenderet
        • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
      • Las Vegas, Nevada, Forenede Stater, 89149
        • Suspenderet
        • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
      • Las Vegas, Nevada, Forenede Stater, 89074
        • Suspenderet
        • Las Vegas Urology - Pecos
      • Las Vegas, Nevada, Forenede Stater, 89102
        • Suspenderet
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Forenede Stater, 89103
        • Suspenderet
        • Hope Cancer Care of Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Suspenderet
        • Radiation Oncology Centers of Nevada Central
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Suspenderet
        • Urology Specialists of Nevada - Central
      • Las Vegas, Nevada, Forenede Stater, 89109
        • Suspenderet
        • Sunrise Hospital and Medical Center
      • Las Vegas, Nevada, Forenede Stater, 89113
        • Suspenderet
        • Las Vegas Prostate Cancer Center
      • Las Vegas, Nevada, Forenede Stater, 89113
        • Suspenderet
        • Las Vegas Urology - Sunset
      • Las Vegas, Nevada, Forenede Stater, 89113
        • Suspenderet
        • Urology Specialists of Nevada - Southwest
      • Las Vegas, Nevada, Forenede Stater, 89119
        • Suspenderet
        • Radiation Oncology Centers of Nevada Southeast
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Suspenderet
        • Ann M Wierman MD LTD
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Suspenderet
        • Comprehensive Cancer Centers of Nevada - Northwest
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Suspenderet
        • Las Vegas Urology - Cathedral Rock
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Suspenderet
        • Las Vegas Urology - Smoke Ranch
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Suspenderet
        • OptumCare Cancer Care at MountainView
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Suspenderet
        • Urology Specialists of Nevada - Northwest
      • Las Vegas, Nevada, Forenede Stater, 89135
        • Suspenderet
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
      • Las Vegas, Nevada, Forenede Stater, 89144
        • Suspenderet
        • Comprehensive Cancer Centers of Nevada - Town Center
      • Las Vegas, Nevada, Forenede Stater, 89144
        • Suspenderet
        • Comprehensive Cancer Centers of Nevada-Summerlin
      • Las Vegas, Nevada, Forenede Stater, 89144
        • Suspenderet
        • Summerlin Hospital Medical Center
      • Las Vegas, Nevada, Forenede Stater, 89148-2405
        • Suspenderet
        • Las Vegas Cancer Center-Medical Center
      • Las Vegas, Nevada, Forenede Stater, 89148
        • Suspenderet
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Forenede Stater, 89169
        • Suspenderet
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, Forenede Stater, 89169
        • Suspenderet
        • University Cancer Center
      • Las Vegas, Nevada, Forenede Stater, 89102
        • Suspenderet
        • OptumCare Cancer Care at Charleston
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Suspenderet
        • Oncology Las Vegas - Tenaya
      • Las Vegas, Nevada, Forenede Stater, 89183
        • Suspenderet
        • OptumCare Cancer Care at Fort Apache
      • Pahrump, Nevada, Forenede Stater, 89048
        • Suspenderet
        • Hope Cancer Care of Nevada-Pahrump
      • Reno, Nevada, Forenede Stater, 89502
        • Suspenderet
        • Renown Regional Medical Center
      • Reno, Nevada, Forenede Stater, 89503
        • Suspenderet
        • Saint Mary's Regional Medical Center
      • Reno, Nevada, Forenede Stater, 89509
        • Suspenderet
        • Radiation Oncology Associates
    • New York
      • Buffalo, New York, Forenede Stater, 14263
        • Aktiv, ikke rekrutterende
        • Roswell Park Cancer Institute
      • Lake Success, New York, Forenede Stater, 11042
        • Rekruttering
        • Northwell Health/Center for Advanced Medicine
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 516-734-8896
        • Ledende efterforsker:
          • Bradley H. Goldberg
      • Manhasset, New York, Forenede Stater, 11030
        • Rekruttering
        • North Shore University Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 516-734-8896
        • Ledende efterforsker:
          • Bradley H. Goldberg
      • New Hyde Park, New York, Forenede Stater, 11040
        • Rekruttering
        • Long Island Jewish Medical Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 516-734-8896
        • Ledende efterforsker:
          • Bradley H. Goldberg
      • New York, New York, Forenede Stater, 10065
        • Aktiv, ikke rekrutterende
        • NYP/Weill Cornell Medical Center
      • Rochester, New York, Forenede Stater, 14642
        • Rekruttering
        • University of Rochester
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 585-275-5830
        • Ledende efterforsker:
          • Kristen M. O'Dwyer
      • Stony Brook, New York, Forenede Stater, 11794
        • Rekruttering
        • Stony Brook University Medical Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 800-862-2215
        • Ledende efterforsker:
          • Suhu Liu
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • Suspenderet
        • UNC Lineberger Comprehensive Cancer Center
      • Durham, North Carolina, Forenede Stater, 27710
        • Aktiv, ikke rekrutterende
        • Duke University Medical Center
      • Greenville, North Carolina, Forenede Stater, 27834
        • Suspenderet
        • East Carolina University
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Rekruttering
        • Wake Forest University Health Sciences
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 336-713-6771
        • Ledende efterforsker:
          • Bayard L. Powell
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Rekruttering
        • University of Cincinnati Cancer Center-UC Medical Center
        • Ledende efterforsker:
          • Emily K. Curran
        • Kontakt:
      • Columbus, Ohio, Forenede Stater, 43210
        • Rekruttering
        • Ohio State University Comprehensive Cancer Center
        • Ledende efterforsker:
          • Gregory K. Behbehani
        • Kontakt:
      • West Chester, Ohio, Forenede Stater, 45069
        • Rekruttering
        • University of Cincinnati Cancer Center-West Chester
        • Ledende efterforsker:
          • Emily K. Curran
        • Kontakt:
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Rekruttering
        • University of Oklahoma Health Sciences Center
        • Kontakt:
        • Ledende efterforsker:
          • Zimu Gong
      • Oklahoma City, Oklahoma, Forenede Stater, 73120
        • Suspenderet
        • Mercy Hospital Oklahoma City
    • Oregon
      • Bend, Oregon, Forenede Stater, 97701
        • Suspenderet
        • Saint Charles Health System
      • Clackamas, Oregon, Forenede Stater, 97015
        • Rekruttering
        • Clackamas Radiation Oncology Center
        • Ledende efterforsker:
          • Alison K. Conlin
        • Kontakt:
      • Clackamas, Oregon, Forenede Stater, 97015
        • Suspenderet
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, Forenede Stater, 97420
        • Suspenderet
        • Bay Area Hospital
      • Newberg, Oregon, Forenede Stater, 97132
        • Rekruttering
        • Providence Newberg Medical Center
        • Ledende efterforsker:
          • Alison K. Conlin
        • Kontakt:
      • Oregon City, Oregon, Forenede Stater, 97045
        • Rekruttering
        • Providence Willamette Falls Medical Center
        • Ledende efterforsker:
          • Alison K. Conlin
        • Kontakt:
      • Portland, Oregon, Forenede Stater, 97213
        • Rekruttering
        • Providence Portland Medical Center
        • Ledende efterforsker:
          • Alison K. Conlin
        • Kontakt:
      • Portland, Oregon, Forenede Stater, 97225
        • Rekruttering
        • Providence Saint Vincent Medical Center
        • Ledende efterforsker:
          • Alison K. Conlin
        • Kontakt:
      • Portland, Oregon, Forenede Stater, 97239
        • Aktiv, ikke rekrutterende
        • Oregon Health and Science University
      • Redmond, Oregon, Forenede Stater, 97756
        • Suspenderet
        • Saint Charles Health System-Redmond
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18103
        • Suspenderet
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, Forenede Stater, 18017
        • Suspenderet
        • Lehigh Valley Hospital - Muhlenberg
      • Chadds Ford, Pennsylvania, Forenede Stater, 19317
        • Suspenderet
        • Christiana Care Health System-Concord Health Center
      • East Stroudsburg, Pennsylvania, Forenede Stater, 18301
        • Suspenderet
        • Pocono Medical Center
      • Hazleton, Pennsylvania, Forenede Stater, 18201
        • Suspenderet
        • Lehigh Valley Hospital-Hazleton
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Aktiv, ikke rekrutterende
        • Thomas Jefferson University Hospital
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23298
        • Rekruttering
        • VCU Massey Comprehensive Cancer Center
        • Ledende efterforsker:
          • Keri R. Maher
        • Kontakt:
    • Washington
      • Aberdeen, Washington, Forenede Stater, 98520
        • Suspenderet
        • Providence Regional Cancer System-Aberdeen
      • Bellevue, Washington, Forenede Stater, 98004
        • Suspenderet
        • Overlake Medical Center
      • Bellingham, Washington, Forenede Stater, 98225
        • Suspenderet
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, Forenede Stater, 98531
        • Suspenderet
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, Forenede Stater, 98026
        • Suspenderet
        • Swedish Cancer Institute-Edmonds
      • Everett, Washington, Forenede Stater, 98201
        • Suspenderet
        • Providence Regional Cancer Partnership
      • Issaquah, Washington, Forenede Stater, 98029
        • Suspenderet
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, Forenede Stater, 99336
        • Suspenderet
        • Kadlec Clinic Hematology and Oncology
      • Lacey, Washington, Forenede Stater, 98503
        • Suspenderet
        • Providence Regional Cancer System-Lacey
      • Longview, Washington, Forenede Stater, 98632
        • Suspenderet
        • PeaceHealth Saint John Medical Center
      • Renton, Washington, Forenede Stater, 98055
        • Suspenderet
        • Valley Medical Center
      • Seattle, Washington, Forenede Stater, 98104
        • Suspenderet
        • Pacific Gynecology Specialists
      • Seattle, Washington, Forenede Stater, 98107
        • Suspenderet
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, Forenede Stater, 98122-5711
        • Suspenderet
        • Swedish Medical Center-Cherry Hill
      • Seattle, Washington, Forenede Stater, 98122
        • Suspenderet
        • Swedish Medical Center-First Hill
      • Sedro-Woolley, Washington, Forenede Stater, 98284
        • Suspenderet
        • PeaceHealth United General Medical Center
      • Shelton, Washington, Forenede Stater, 98584
        • Suspenderet
        • Providence Regional Cancer System-Shelton
      • Vancouver, Washington, Forenede Stater, 98664
        • Suspenderet
        • PeaceHealth Southwest Medical Center
      • Walla Walla, Washington, Forenede Stater, 99362
        • Suspenderet
        • Providence Saint Mary Regional Cancer Center
      • Yakima, Washington, Forenede Stater, 98902
        • Suspenderet
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
      • Yelm, Washington, Forenede Stater, 98597
        • Suspenderet
        • Providence Regional Cancer System-Yelm
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater, 26506
        • Aktiv, ikke rekrutterende
        • West Virginia University Healthcare
    • Wisconsin
      • Eau Claire, Wisconsin, Forenede Stater, 54701
      • Madison, Wisconsin, Forenede Stater, 53792
        • Aktiv, ikke rekrutterende
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Madison, Wisconsin, Forenede Stater, 53718
        • Aktiv, ikke rekrutterende
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
      • Marshfield, Wisconsin, Forenede Stater, 54449
      • Menomonee Falls, Wisconsin, Forenede Stater, 53051
        • Rekruttering
        • Froedtert Menomonee Falls Hospital
        • Ledende efterforsker:
          • Ehab L. Atallah
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 262-257-5100
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Rekruttering
        • Medical College of Wisconsin
        • Ledende efterforsker:
          • Ehab L. Atallah
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 414-805-3666
      • Minocqua, Wisconsin, Forenede Stater, 54548
      • New Berlin, Wisconsin, Forenede Stater, 53151
        • Rekruttering
        • Froedtert and MCW Moorland Reserve Health Center
        • Ledende efterforsker:
          • Ehab L. Atallah
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 414-805-0505
      • Oak Creek, Wisconsin, Forenede Stater, 53154
        • Rekruttering
        • Drexel Town Square Health Center
        • Ledende efterforsker:
          • Ehab L. Atallah
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 414-805-0505
      • Rice Lake, Wisconsin, Forenede Stater, 54868
      • Stevens Point, Wisconsin, Forenede Stater, 54482
      • West Bend, Wisconsin, Forenede Stater, 53095
        • Rekruttering
        • Froedtert West Bend Hospital/Kraemer Cancer Center
        • Ledende efterforsker:
          • Ehab L. Atallah
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 414-805-0505
      • Weston, Wisconsin, Forenede Stater, 54476
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Rekruttering
        • Centro Comprensivo de Cancer de UPR
        • Ledende efterforsker:
          • Luis J. Santos Reyes
        • Kontakt:
      • San Juan, Puerto Rico, 00936
        • Rekruttering
        • San Juan City Hospital
        • Ledende efterforsker:
          • Luis J. Santos Reyes
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 787-763-1296

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • STEP 0: Submission of bone marrow aspirate and peripheral blood for MRD analysis is mandatory prior to registration; the bone marrow sample should be from the first aspiration (i.e. first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be initiated as soon as possible after pre-registration. The specimens should be sent to the HEME Biobank.

    • Lumbar Puncture (Spinal Tap) and Intrathecal Methotrexate:

      • Patients may receive the day 1 of course IA dose of intrathecal (IT) methotrexate during the prior-to-registration lumbar puncture (or the venous line placement) to avoid a second lumbar puncture. If the dose is administered prior to registration, then systemic chemotherapy must begin within 7 days of this IT chemotherapy.

  • STEP 1: Morphologic diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL) based on World Health Organization (WHO) criteria. Patients with Burkitt lymphoma/leukemia are not eligible.

  • STEP 1: CD22-positive disease defined as CD22 expression by >= 20% of lymphoblasts by local hematopathology evaluation.

  • STEP 1: Philadelphia chromosome/BCR-ABL1-negative or Philadelphia chromosome/BCR-ABL1-positive B-cell ALL by cytogenetics, fluorescence in situ hybridization (FISH), and/or polymerase chain reaction (PCR).

  • STEP 1: No active central nervous system (CNS) leukemia (i.e. only CNS-1 disease allowed). Active CNS leukemia is defined as morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS-directed local treatment for active disease within 28 days prior to registration, symptomatic CNS leukemia (i.e. cranial nerve palsies or other significant neurological dysfunction) within the 28 days prior to registration, and/or known asymptomatic parenchymal CNS mass lesions; see below for additional guidance. Prophylactic intrathecal medication alone is not an exclusion.

    • Categories of CNS Involvement for CNS Evaluation Prior to Registration:

      • CNS 1: CSF has < 5 WBC/uL with cytospin negative for blasts; or >= 10 red blood cell (RBC)/uL with cytospin negative for blasts.

      • CNS 2: CSF has < 5 WBC/uL with cytospin positive for blasts; or >= 10 RBC/uL with cytospin positive for blasts; or >= 10 RBC/uL, WBC/uL >= 5 but less than Steinherz/Bleyer algorithm with cytospin positive for blasts (see below).

      • CNS 3: CSF has >= 5 WBC/uL with cytospin positive for blasts; or >= 10 RBC/uL, >= 5 WBC/uL and positive by Steinherz/Bleyer algorithm (see below); or clinical signs of CNS leukemia (such as facial nerve palsy, brain/eye involvement or hypothalamic syndrome). Steinherz/Bleyer Method of Evaluating Initial Traumatic Lumbar Punctures:

        • If the patient has leukemia cells in the peripheral blood and the lumbar puncture is traumatic and contains >= 5 WBC/uL with blasts, the following algorithm should be used to define CNS disease: CSF WBC/CSF RBC > 2 x (Blood WBC/Blood RBC count)

  • STEP 1: Patients with known or suspected testicular involvement by leukemia are allowed provided that the patient receives concomitant scrotal/testicular radiotherapy.

    • Unilateral or bilateral testicular enlargement should be assessed by ultrasound or other imaging technique. Biopsy is recommended if clinical findings are equivocal or suggestive of hydrocele or a non-leukemic mass, but further assessments are per treating physician discretion.

  • STEP 1: Not pregnant and not nursing.

    • This study involves agents that have known genotoxic, mutagenic, and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required.

  • STEP 1: Eastern Cooperative Oncology Group (ECOG) performance status: 0-2

  • STEP 1: No unstable cardiac disease such as myocardial infarction, angina pectoris, uncontrolled heart failure, or uncontrolled cardiac arrhythmia within 6 months of registration.

  • STEP 1: No impaired cardiac function, defined as left ventricular ejection fraction (LVEF) < 45% or New York Heart Association (NYHA) stage III or IV congestive heart failure (CHF).

  • STEP 1: Patients with known human immunodeficiency virus (HIV) infection are eligible if they have been on effective antiretroviral therapy with an undetectable viral load tested within 6 months of registration.

  • STEP 1: Patients with hepatitis B virus (HBV) are eligible only if they meet all the following:

    • On HBV-suppressive therapy.
    • No evidence of active virus.
    • No evidence of HBV-related liver damage.

  • STEP 1: Patients with hepatitis C virus (HCV) are eligible only if they meet all the following:

    • Successfully completed complete-eradication therapy with undetectable viral load.
    • No evidence of HCV-related liver damage.

  • STEP 1: No history of clinically relevant neurologic disorder such as epilepsy, seizure, aphasia, stroke, severe brain injury, structural brain abnormality, benign brain tumor, dementia, Parkinson's disease, movement disorder, cerebellar disease, or other significant CNS abnormalities.

  • STEP 1: No prior additional malignancy (i.e. in addition to ALL) except adequately treated basal- or squamous-cell skin cancer, in situ cervical cancer, stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for >= 2 years.

  • STEP 1: No history of clinically significant ventricular arrhythmia, unexplained non-vasovagal syncope, or chronic bradycardic states such as sinoatrial block or higher degree of atrioventricular block unless a permanent pacemaker has been implanted.

  • STEP 1: No history of chronic liver disease, including cirrhosis.

  • STEP 1: No history of sinusoidal occlusion syndrome/veno-occlusive disease of the liver.

  • STEP 1: No uncontrolled infection or recent history (within 4 months prior to registration) of deep tissue infections such as fasciitis or osteomyelitis.

  • STEP 1: Total bilirubin, serum =< 1.5 x upper limit of normal (ULN)*

    • Except in the event of: 1) Gilbert disease, in which case total bilirubin must be =< 2 x ULN, or 2) elevated bilirubin believed by investigator to be due to leukemic infiltration, in which case total bilirubin must be =< 2 x ULN.

  • STEP 1: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN

  • STEP 1: Creatinine, serum =< 1.5 ULN OR creatinine clearance >= 40 mL/min

  • STEP 1: QT interval by Fridericia's correction formula (QTcF) =< 470 msec

  • COHORT 1: Age >= 60 years.

  • COHORT 1: Diagnosis of Philadelphia chromosome/BCR-ABL1-negative B-cell ALL.

  • COHORT 1: No prior treatment for ALL except a single dose of intrathecal chemotherapy, corticosteroids, hydroxyurea, and/or leukapheresis to reduce peripheral blast count and prevent ALL complications. Allowed therapy may be administered for no more than 14 days and must be completed >= 24 hours prior to the initiation of protocol therapy.

  • COHORT 1: No plan for allogeneic or autologous hematopoietic cell transplantation (HCT).

  • COHORT 2: Age >= 18 years.

  • COHORT 2: Diagnosis of Philadelphia chromosome/BCR-ABL1-negative B-cell ALL.

  • COHORT 2: Relapsed or refractory disease in salvage 1 or 2.

  • COHORT 2: No isolated extramedullary relapse.

  • COHORT 2: Prior allogeneic HCT permitted.

  • COHORT 2: Patients with prior allogeneic HCT must have completed transplantation >= 4 months prior to registration.

  • COHORT 2: Patients with prior allogeneic HCT must have no evidence of graft-versus-host disease and must have completed immunosuppressive therapy >= 30 days prior to registration.

  • COHORT 2: Prior treatment with inotuzumab ozogamicin, blinatumomab, other CD22-directed therapy, or other CD19-directed therapy is not allowed.

  • COHORT 2: Prior treatment with rituximab must be completed >= 7 days prior to registration.

  • COHORT 2: Prior treatment with other monoclonal antibodies must be completed >= 6 weeks prior to registration.

  • COHORT 2: Prior treatment for ALL must be completed >= 14 days prior to registration with the following exceptions: intrathecal chemotherapy, hydroxyurea, corticosteroids, 6-mercaptopurine, methotrexate, vincristine, and/or leukapheresis to reduce circulating absolute lymphoblast count to =< 10,000/uL or prevent complications related to ALL are allowed but must be completed >= 24 hours prior to the initiation of protocol therapy.

  • COHORT 2: Patients should have resolution of any acute non-hematologic toxicities of prior therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 grade =< 1.

  • COHORT 2: Peripheral blood absolute lymphoblast count =< 10,000/uL (treatment allowed as above to reduce blast count to =< 10,000/uL)

  • COHORT 3: Age ≥ 75 years OR age ≥ 18 years AND ineligible for hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (HyperCVAD) regimens

  • COHORT 3: Diagnosis of Philadelphia chromosome/BCR-ABL1-positive B-cell ALL

  • COHORT 3: No prior treatment for ALL except a single dose of intrathecal chemotherapy, corticosteroids, hydroxyurea, BCR-ABL1-targeted tyrosine kinase inhibitor, and/or leukapheresis to reduce peripheral blast count and prevent ALL complications. Allowed non-protocol therapy may be administered for no more than 14 days and must be completed ≥ 24 hours prior to the initiation of protocol therapy.

  • COHORT 3: No chronic, strong CYP3A4 inducers

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: Ikke-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: Cohort 1 (inotuzumab ozogamicin, blinatumomab)

See Detailed Description..
Procedure: Bone Marrow Biopsy

Undergo bone marrow biopsy

Andre navne:
  • Biopsi af knoglemarv
  • Biopsi, knoglemarv
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: Lumbar Puncture

Undergo lumbar puncture

Andre navne:
  • LP
  • Spinal Tap
Biologisk: Inotuzumab Ozogamicin

Given IV

Andre navne:
  • Besponsa
  • CMC-544
  • Vej 207294
  • WAY-207294
  • CMC 544
  • CMC544
Procedure: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Eksperimentel: Cohort 2 (inotuzumab ozogamicin, blinatumomab)

See Detailed Description.
Procedure: Bone Marrow Biopsy

Undergo bone marrow biopsy

Andre navne:
  • Biopsi af knoglemarv
  • Biopsi, knoglemarv
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

Procedure: Lumbar Puncture

Undergo lumbar puncture

Andre navne:
  • LP
  • Spinal Tap
Biologisk: Inotuzumab Ozogamicin

Given IV

Andre navne:
  • Besponsa
  • CMC-544
  • Vej 207294
  • WAY-207294
  • CMC 544
  • CMC544
Procedure: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Eksperimentel: Cohort 3 (inotuzumab ozogamicin, blinatumomab, ponatinib))

See detailed description
Procedure: Bone Marrow Biopsy

Undergo bone marrow biopsy

Andre navne:
  • Biopsi af knoglemarv
  • Biopsi, knoglemarv
Medicin: Ponatinib

Given PO

Andre navne:
  • AP-24534
  • AP24534
  • AP 24534
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

Procedure: Lumbar Puncture

Undergo lumbar puncture

Andre navne:
  • LP
  • Spinal Tap
Biologisk: Inotuzumab Ozogamicin

Given IV

Andre navne:
  • Besponsa
  • CMC-544
  • Vej 207294
  • WAY-207294
  • CMC 544
  • CMC544
Procedure: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

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

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
Event-free survival
Tidsramme: At 1 year

Will be defined as time from start of treatment to failure to achieve complete response (CR)/complete response with incomplete count recovery (CRi) after completing Course II of blinatumomab, relapse after CR/CRi, progression on study requiring withdrawal from study therapy, or death from any cause
At 1 year
Completion of protocol treatment (cohort 3)
Tidsramme: Up to 10 years

Feasibility defined as completion of the planned therapy as defined in the protocol. Success rate defined as the proportion of patients who either complete entire protocol treatment or go off protocol treatment due to the disease (e.g., refractory disease, progression, and relapse).
Up to 10 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
Minimal resterende sygdomsnegativitet
Tidsramme: Op til 10 år
Op til 10 år
Overall survival (OS)
Tidsramme: Time from start of study therapy to death from any cause censored at the last known alive date, assessed up to 10 years

Will be evaluated using the Kaplan-Meier method. A 95% confidence interval for the 1- and 3-year rates will be constructed using a point-wise confidence interval for the survival function based on a log-minus-log transformation. Will also calculate a 95% confidence interval by using a point-wise confidence interval for the survival function based on a log-minus-log transformation.
Time from start of study therapy to death from any cause censored at the last known alive date, assessed up to 10 years
Relapse-free survival (RFS)
Tidsramme: Time from first CR/CRi to progressive disease (relapse, treatment discontinuation due to health deterioration) or death, assessed up to 10 years

Will be evaluated using the Kaplan-Meier method. A 95% confidence interval for the 1- and 3-year rates will be constructed using a point-wise confidence interval for the survival function based on a log-minus-log transformation. Will also calculate a 95% confidence interval by using a point-wise confidence interval for the survival function based on a log-minus-log transformation.
Time from first CR/CRi to progressive disease (relapse, treatment discontinuation due to health deterioration) or death, assessed up to 10 years
Event-free survival (EFS)
Tidsramme: Time from start of treatment to failure to achieve CR/CRi after completing Course II of blinatumomab, relapse after CR/CRi, progression on study requiring withdrawal from study therapy, or death from any cause, assessed up to 10 years

Will be evaluated using the Kaplan-Meier method. A 95% confidence interval for the 1- and 3-year rates will be constructed using a point-wise confidence interval for the survival function based on a log-minus-log transformation. Will also calculate a 95% confidence interval by using a point-wise confidence interval for the survival function based on a log-minus-log transformation.
Time from start of treatment to failure to achieve CR/CRi after completing Course II of blinatumomab, relapse after CR/CRi, progression on study requiring withdrawal from study therapy, or death from any cause, assessed up to 10 years
Complete and overall response rate
Tidsramme: Up to 10 years

Point and interval estimates of the rates will be shown using a 95% binomial confidence interval.
Up to 10 years
Complete molecular response
Tidsramme: Up to 10 years

Defined as negative BCR-ABL1 quantitative real time polymerase chain reaction on bone marrow aspirate in patients in CR/complete response with partial hematologic recovery/CRi.
Up to 10 years
Allogeneic hematopoietic cell transplantation rate (Cohort 2)
Tidsramme: Up to 10 years

Point and interval estimates of the rate will be shown using a 95% binomial confidence interval.
Up to 10 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
Rate of cytokine release syndrome (Cohort 1)
Tidsramme: Up to 10 years

Point and interval estimates of the rate will be shown using a 95% binomial confidence interval.
Up to 10 years
Sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver
Tidsramme: Up to 10 years

The rate of, timing of, and risk factors for SOS/VOD of the liver after limited inotuzumab ozogamicin exposure. Point and interval estimates of the rate will be shown using a 95% binomial confidence interval. A summary of the timing and risk factors for SOS/VOD of the liver will be provided.
Up to 10 years
OS
Tidsramme: Up to 2 years

Will compare between patients achieving CR/CRi and receiving consolidation with allogeneic hematopoietic cell transplantation versus (vs.) patients achieving CR/CRi and receiving consolidation without allogeneic hematopoietic cell transplantation. The median, 1-year, and 2-year OS will be compared between the above two groups. The distribution of OS for each group will be estimated using the Kaplan-Meier method.
Up to 2 years
RFS
Tidsramme: Up to 2 years

Will compare between patients achieving CR/CRi and receiving consolidation with allogeneic hematopoietic cell transplantation vs. patients achieving CR/CRi and receiving consolidation without allogeneic hematopoietic cell transplantation. The median, 1-year, and 2-year RFS will be compared between the above two groups. The distribution of RFS for each treatment arm will be estimated using the Kaplan-Meier method.
Up to 2 years
Cumulative incidence of relapse (CIR)
Tidsramme: Up to 2 years

Will compare between patients achieving CR/CRi and receiving consolidation with allogeneic hematopoietic cell transplantation vs. patients achieving CR/CRi and receiving consolidation without allogeneic hematopoietic cell transplantation. Competing risk analysis will be done to compare the relapse rates between the above two groups. In this analysis, death will be considered a competing event. Relapse rates at the 1-year and 2-year time points will be estimated. Other time points of interest may be estimated as well.
Up to 2 years
Non-relapse mortality
Tidsramme: Up to 2 years

Will compare between patients achieving CR/CRi and receiving consolidation with allogeneic hematopoietic cell transplantation vs. patients achieving CR/CRi and receiving consolidation without allogeneic hematopoietic cell transplantation. Competing risk analysis will be done to compare the mortality rates between the above two groups. In this analysis, relapse will be considered a competing event. Mortality rates at the 1-year and 2-year time points will be estimated. Other time points may be estimated as well.
Up to 2 years

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: Matthew J Wieduwilt, Alliance for Clinical Trials in Oncology

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.
8. maj 2019

Primær færdiggørelse (Anslået)

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.
1. februar 2027

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.
1. 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).
12. november 2018

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.
12. november 2018

Først opslået (Faktiske)

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.
14. november 2018

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.
12. 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. august 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-2018-02484
  • U10CA180821 (U.S. NIH-bevilling/kontrakt)
  • NCI-2018-02484 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • A041703 (Anden identifikator: CTEP)
  • A041703 (Anden identifikator: Alliance for Clinical Trials in Oncology)

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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