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Inotuzumab Ozogamicin et Blinatumomab dans le traitement des patients atteints d'une leucémie aiguë lymphoblastique de lignée B nouvellement diagnostiquée, récurrente ou réfractaire

11 novembre 2026 mis à jour par: National Cancer Institute (NCI)

Une étude de phase II sur l'inotuzumab ozogamicine suivi de blinatumomab pour la leucémie aiguë lymphoblastique Ph-négative CD22-positive chez les personnes âgées nouvellement diagnostiquées ou les adultes atteints d'une maladie récidivante ou réfractaire

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

84

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Porto Rico
      • San Juan, Porto Rico, 00927
        • Recrutement
        • Centro Comprensivo de Cancer de UPR
        • Chercheur principal:
          • Luis J. Santos Reyes
        • Contact:
      • San Juan, Porto Rico, 00936
        • Recrutement
        • San Juan City Hospital
        • Chercheur principal:
          • Luis J. Santos Reyes
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 787-763-1296
  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 35233
        • Actif, ne recrute pas
        • University of Alabama at Birmingham Cancer Center
    • Alaska
      • Anchorage, Alaska, États-Unis, 98508
        • Suspendu
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, États-Unis, 99504
        • Suspendu
        • Anchorage Radiation Therapy Center
      • Anchorage, Alaska, États-Unis, 99508
        • Suspendu
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, États-Unis, 99508
        • Suspendu
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, États-Unis, 99508
        • Suspendu
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, États-Unis, 99508
        • Suspendu
        • Anchorage Oncology Centre
      • Anchorage, Alaska, États-Unis, 99508
        • Suspendu
        • Katmai Oncology Group
      • Anchorage, Alaska, États-Unis, 99508
        • Suspendu
        • Providence Alaska Medical Center
    • Arizona
      • Kingman, Arizona, États-Unis, 86401
        • Suspendu
        • Kingman Regional Medical Center
    • Arkansas
      • Fort Smith, Arkansas, États-Unis, 72903
        • Suspendu
        • Mercy Hospital Fort Smith
    • California
      • Arroyo Grande, California, États-Unis, 93420
        • Suspendu
        • PCR Oncology
      • Burbank, California, États-Unis, 91505
        • Suspendu
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Clovis, California, États-Unis, 93611
        • Actif, ne recrute pas
        • Community Cancer Institute
      • Clovis, California, États-Unis, 93611
        • Actif, ne recrute pas
        • University Oncology Associates
      • Duarte, California, États-Unis, 91010
        • Recrutement
        • City of Hope Comprehensive Cancer Center
        • Contact:
        • Chercheur principal:
          • Ibrahim Aldoss
      • Irvine, California, États-Unis, 92612
        • Recrutement
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
        • Chercheur principal:
          • Deepa Jeyakumar
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 877-827-8839
          • E-mail: ucstudy@uci.edu
      • La Jolla, California, États-Unis, 92093
        • Recrutement
        • UC San Diego Moores Cancer Center
        • Chercheur principal:
          • James K. Mangan
        • Contact:
      • Orange, California, États-Unis, 92868
        • Recrutement
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Chercheur principal:
          • Deepa Jeyakumar
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 877-827-8839
          • E-mail: ucstudy@uci.edu
      • Palo Alto, California, États-Unis, 94304
        • Actif, ne recrute pas
        • Stanford Cancer Institute Palo Alto
    • Delaware
      • Lewes, Delaware, États-Unis, 19958
        • Suspendu
        • Beebe Medical Center
      • Millville, Delaware, États-Unis, 19967
        • Suspendu
        • Beebe South Coastal Health Campus
      • Newark, Delaware, États-Unis, 19713
        • Recrutement
        • Helen F Graham Cancer Center
        • Chercheur principal:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, États-Unis, 19713
        • Suspendu
        • Delaware Clinical and Laboratory Physicians PA
      • Newark, Delaware, États-Unis, 19713
        • Recrutement
        • Medical Oncology Hematology Consultants PA
        • Chercheur principal:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, États-Unis, 19718
        • Suspendu
        • Christiana Care Health System-Christiana Hospital
      • Rehoboth Beach, Delaware, États-Unis, 19971
        • Suspendu
        • Beebe Health Campus
      • Seaford, Delaware, États-Unis, 19973
        • Suspendu
        • TidalHealth Nanticoke / Allen Cancer Center
      • Wilmington, Delaware, États-Unis, 19801
        • Suspendu
        • Christiana Care Health System-Wilmington Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, États-Unis, 20007
        • Recrutement
        • MedStar Georgetown University Hospital
        • Chercheur principal:
          • Kimberley Doucette
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 202-444-2223
    • Florida
      • Fort Lauderdale, Florida, États-Unis, 33308
        • Suspendu
        • Holy Cross Hospital
      • Jupiter, Florida, États-Unis, 33458
        • Recrutement
        • Jupiter Medical Center
        • Chercheur principal:
          • Ryan H. Devine
        • Contact:
    • Georgia
      • Atlanta, Georgia, États-Unis, 30322
        • Recrutement
        • Emory University Hospital/Winship Cancer Institute
        • Chercheur principal:
          • William G. Blum
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 404-778-1868
      • Atlanta, Georgia, États-Unis, 30342
        • Recrutement
        • Emory Saint Joseph's Hospital
        • Chercheur principal:
          • William G. Blum
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 404-851-7115
    • Idaho
      • Boise, Idaho, États-Unis, 83712
        • Suspendu
        • Saint Luke's Cancer Institute - Boise
      • Fruitland, Idaho, États-Unis, 83619
        • Suspendu
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, États-Unis, 83642
        • Suspendu
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, États-Unis, 83687
        • Recrutement
        • Saint Alphonsus Cancer Care Center-Nampa
        • Contact:
        • Chercheur principal:
          • Christopher M. Reynolds
      • Nampa, Idaho, États-Unis, 83687
        • Suspendu
        • Saint Luke's Cancer Institute - Nampa
      • Twin Falls, Idaho, États-Unis, 83301
        • Suspendu
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Alton, Illinois, États-Unis, 62002
        • Suspendu
        • OSF Saint Anthony's Health Center
      • Bloomington, Illinois, États-Unis, 61704
        • Suspendu
        • Illinois CancerCare-Bloomington
      • Burr Ridge, Illinois, États-Unis, 60527
        • Suspendu
        • Loyola Center for Health at Burr Ridge
      • Canton, Illinois, États-Unis, 61520
        • Suspendu
        • Illinois CancerCare-Canton
      • Carbondale, Illinois, États-Unis, 62902
        • Suspendu
        • Memorial Hospital of Carbondale
      • Carterville, Illinois, États-Unis, 62918
        • Suspendu
        • SIH Cancer Institute
      • Carthage, Illinois, États-Unis, 62321
        • Suspendu
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, États-Unis, 62801
        • Suspendu
        • Centralia Oncology Clinic
      • Chicago, Illinois, États-Unis, 60637
        • Recrutement
        • University of Chicago Comprehensive Cancer Center
        • Chercheur principal:
          • Wendy Stock
        • Contact:
      • Chicago, Illinois, États-Unis, 60611
        • Recrutement
        • Northwestern University
        • Chercheur principal:
          • Shira N. Dinner
        • Contact:
      • Chicago, Illinois, États-Unis, 60612
        • Recrutement
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 312-355-3046
        • Chercheur principal:
          • John G. Quigley
      • Decatur, Illinois, États-Unis, 62526
        • Recrutement
        • Cancer Care Specialists of Illinois - Decatur
        • Chercheur principal:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, États-Unis, 62526
        • Suspendu
        • Decatur Memorial Hospital
      • Dixon, Illinois, États-Unis, 61021
        • Suspendu
        • Illinois CancerCare-Dixon
      • Effingham, Illinois, États-Unis, 62401
        • Recrutement
        • Crossroads Cancer Center
        • Chercheur principal:
          • Bryan A. Faller
        • Contact:
      • Eureka, Illinois, États-Unis, 61530
        • Suspendu
        • Illinois CancerCare-Eureka
      • Evanston, Illinois, États-Unis, 60201
        • Recrutement
        • NorthShore University HealthSystem-Evanston Hospital
        • Chercheur principal:
          • Amy Y. Wang
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 847-570-2109
      • Galesburg, Illinois, États-Unis, 61401
        • Suspendu
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, États-Unis, 61401
        • Suspendu
        • Illinois CancerCare-Galesburg
      • Glenview, Illinois, États-Unis, 60026
        • Recrutement
        • NorthShore University HealthSystem-Glenbrook Hospital
        • Chercheur principal:
          • Amy Y. Wang
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 847-570-2109
      • Highland Park, Illinois, États-Unis, 60035
        • Recrutement
        • NorthShore University HealthSystem-Highland Park Hospital
        • Chercheur principal:
          • Amy Y. Wang
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 847-570-2109
      • Homer Glen, Illinois, États-Unis, 60491
        • Suspendu
        • Loyola Medicine Homer Glen
      • Kewanee, Illinois, États-Unis, 61443
        • Suspendu
        • Illinois CancerCare-Kewanee Clinic
      • Lake Forest, Illinois, États-Unis, 60045
        • Actif, ne recrute pas
        • Northwestern Medicine Lake Forest Hospital
      • Macomb, Illinois, États-Unis, 61455
        • Suspendu
        • Illinois CancerCare-Macomb
      • Maywood, Illinois, États-Unis, 60153
        • Recrutement
        • Loyola University Medical Center
        • Chercheur principal:
          • Stephanie B. Tsai
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 708-226-4357
      • Melrose Park, Illinois, États-Unis, 60160
        • Suspendu
        • Marjorie Weinberg Cancer Center at Loyola-Gottlieb
      • Mount Vernon, Illinois, États-Unis, 62864
        • Suspendu
        • SSM Health Good Samaritan
      • New Lenox, Illinois, États-Unis, 60451
        • Recrutement
        • UC Comprehensive Cancer Center at Silver Cross
        • Chercheur principal:
          • Wendy Stock
        • Contact:
      • O'Fallon, Illinois, États-Unis, 62269
        • Suspendu
        • Cancer Care Center of O'Fallon
      • Orland Park, Illinois, États-Unis, 60462
        • Recrutement
        • University of Chicago Medicine-Orland Park
        • Chercheur principal:
          • Wendy Stock
        • Contact:
      • Ottawa, Illinois, États-Unis, 61350
        • Suspendu
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, États-Unis, 61554
        • Suspendu
        • Illinois CancerCare-Pekin
      • Pekin, Illinois, États-Unis, 61554
        • Suspendu
        • OSF Saint Francis Radiation Oncology at Pekin
      • Peoria, Illinois, États-Unis, 61615
        • Recrutement
        • Illinois CancerCare-Peoria
        • Contact:
        • Chercheur principal:
          • Bryan A. Faller
      • Peoria, Illinois, États-Unis, 61636
        • Suspendu
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, États-Unis, 61615
        • Suspendu
        • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
      • Peoria, Illinois, États-Unis, 61637
        • Suspendu
        • OSF Saint Francis Medical Center
      • Peru, Illinois, États-Unis, 61354
        • Suspendu
        • Valley Radiation Oncology
      • Peru, Illinois, États-Unis, 61354
        • Suspendu
        • Illinois CancerCare-Peru
      • Princeton, Illinois, États-Unis, 61356
        • Suspendu
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, États-Unis, 62702
        • Suspendu
        • Springfield Clinic
      • Springfield, Illinois, États-Unis, 62702
        • Suspendu
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, États-Unis, 62781
        • Suspendu
        • Springfield Memorial Hospital
      • Washington, Illinois, États-Unis, 61571
        • Suspendu
        • Illinois CancerCare - Washington
    • Iowa
      • Ankeny, Iowa, États-Unis, 50023
        • Recrutement
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 515-241-3305
        • Chercheur principal:
          • Seema Harichand-Herdt
      • Clive, Iowa, États-Unis, 50325
        • Recrutement
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 515-241-3305
        • Chercheur principal:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, États-Unis, 50309
        • Recrutement
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 515-241-3305
        • Chercheur principal:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, États-Unis, 50314
        • Recrutement
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 515-241-3305
        • Chercheur principal:
          • Seema Harichand-Herdt
      • Waukee, Iowa, États-Unis, 50263
        • Recrutement
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 515-241-3305
        • Chercheur principal:
          • Seema Harichand-Herdt
    • Kansas
      • Garden City, Kansas, États-Unis, 67846
        • Suspendu
        • Central Care Cancer Center - Garden City
      • Great Bend, Kansas, États-Unis, 67530
        • Suspendu
        • Central Care Cancer Center - Great Bend
      • Kansas City, Kansas, États-Unis, 66160
        • Recrutement
        • University of Kansas Cancer Center
        • Chercheur principal:
          • Kenneth Byrd
        • Contact:
      • Westwood, Kansas, États-Unis, 66205
        • Recrutement
        • University of Kansas Hospital-Westwood Cancer Center
        • Chercheur principal:
          • Kenneth Byrd
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, États-Unis, 70121
        • Actif, ne recrute pas
        • Ochsner Medical Center Jefferson
    • Maryland
      • Baltimore, Maryland, États-Unis, 21201
        • Actif, ne recrute pas
        • University of Maryland/Greenebaum Cancer Center
    • Massachusetts
      • Springfield, Massachusetts, États-Unis, 01104
        • Actif, ne recrute pas
        • Mercy Medical Center
    • Michigan
      • Ann Arbor, Michigan, États-Unis, 48106
        • Recrutement
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
        • Contact:
        • Chercheur principal:
          • Christopher M. Reynolds
      • Brighton, Michigan, États-Unis, 48114
        • Recrutement
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Chercheur principal:
          • Christopher M. Reynolds
      • Brighton, Michigan, États-Unis, 48114
        • Recrutement
        • Trinity Health Medical Center - Brighton
        • Contact:
        • Chercheur principal:
          • Christopher M. Reynolds
      • Canton, Michigan, États-Unis, 48188
        • Recrutement
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contact:
        • Chercheur principal:
          • Christopher M. Reynolds
      • Canton, Michigan, États-Unis, 48188
        • Recrutement
        • Trinity Health Medical Center - Canton
        • Contact:
        • Chercheur principal:
          • Christopher M. Reynolds
      • Caro, Michigan, États-Unis, 48723
        • Suspendu
        • Caro Cancer Center
      • Chelsea, Michigan, États-Unis, 48118
        • Recrutement
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Chercheur principal:
          • Christopher M. Reynolds
      • Chelsea, Michigan, États-Unis, 48118
      • Clarkston, Michigan, États-Unis, 48346
        • Suspendu
        • Hematology Oncology Consultants-Clarkston
      • Clarkston, Michigan, États-Unis, 48346
        • Suspendu
        • Newland Medical Associates-Clarkston
      • Detroit, Michigan, États-Unis, 48236
        • Recrutement
        • Henry Ford Health Saint John Hospital
        • Chercheur principal:
          • Christopher M. Reynolds
        • Contact:
      • East China Township, Michigan, États-Unis, 48054
        • Recrutement
        • Henry Ford River District Hospital
        • Chercheur principal:
          • Christopher M. Reynolds
        • Contact:
      • Flint, Michigan, États-Unis, 48503
        • Recrutement
        • Genesys Hurley Cancer Institute
        • Chercheur principal:
          • Christopher M. Reynolds
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 810-762-8038
          • E-mail: wstrong@ghci.org
      • Flint, Michigan, États-Unis, 48503
        • Recrutement
        • Hurley Medical Center
        • Chercheur principal:
          • Christopher M. Reynolds
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 810-762-8038
          • E-mail: wstrong@ghci.org
      • Flint, Michigan, États-Unis, 48503
        • Suspendu
        • Genesee Hematology Oncology PC
      • Flint, Michigan, États-Unis, 48503
        • Recrutement
        • Cancer Hematology Centers - Flint
        • Chercheur principal:
          • Christopher M. Reynolds
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 810-762-8038
          • E-mail: wstrong@ghci.org
      • Grosse Pointe Woods, Michigan, États-Unis, 48236
        • Suspendu
        • Henry Ford Saint John Hospital - Breast
      • Grosse Pointe Woods, Michigan, États-Unis, 48236
        • Recrutement
        • Henry Ford Saint John Hospital - Academic
        • Chercheur principal:
          • Christopher M. Reynolds
        • Contact:
      • Grosse Pointe Woods, Michigan, États-Unis, 48236
        • Recrutement
        • Henry Ford Saint John Hospital - Van Elslander
        • Chercheur principal:
          • Christopher M. Reynolds
        • Contact:
      • Lansing, Michigan, États-Unis, 48912
        • Suspendu
        • University of Michigan Health - Sparrow Lansing
      • Livonia, Michigan, États-Unis, 48154
        • Suspendu
        • Hope Cancer Clinic
      • Livonia, Michigan, États-Unis, 48154
        • Recrutement
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Chercheur principal:
          • Christopher M. Reynolds
      • Macomb, Michigan, États-Unis, 48044
        • Suspendu
        • Henry Ford Warren Hospital - Breast Macomb
      • Macomb, Michigan, États-Unis, 48044
        • Recrutement
        • Henry Ford Saint John Hospital - Macomb Medical
        • Chercheur principal:
          • Christopher M. Reynolds
        • Contact:
      • Marlette, Michigan, États-Unis, 48453
        • Suspendu
        • Saint Mary's Oncology/Hematology Associates of Marlette
      • Pontiac, Michigan, États-Unis, 48341
        • Suspendu
        • Hope Cancer Center
      • Pontiac, Michigan, États-Unis, 48341
        • Recrutement
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Contact:
        • Chercheur principal:
          • Christopher M. Reynolds
      • Pontiac, Michigan, États-Unis, 48341
        • Suspendu
        • Michigan Healthcare Professionals Pontiac
      • Pontiac, Michigan, États-Unis, 48341
        • Suspendu
        • Trinity Health IHA Medical Group-Alice Gustafson Center
      • Rochester Hills, Michigan, États-Unis, 48309
        • Suspendu
        • Henry Ford Rochester Hospital
      • Saginaw, Michigan, États-Unis, 48604
        • Suspendu
        • Oncology Hematology Associates of Saginaw Valley PC
      • Saginaw, Michigan, États-Unis, 48601
        • Recrutement
        • MyMichigan Medical Center Saginaw
        • Contact:
        • Chercheur principal:
          • Christopher M. Reynolds
      • Sterling Heights, Michigan, États-Unis, 48312
        • Suspendu
        • Bhadresh Nayak MD PC-Sterling Heights
      • Tawas City, Michigan, États-Unis, 48764
        • Recrutement
        • MyMichigan Medical Center Tawas
        • Contact:
        • Chercheur principal:
          • Christopher M. Reynolds
      • Warren, Michigan, États-Unis, 48088
        • Suspendu
        • Advanced Breast Care Center PLLC
      • Warren, Michigan, États-Unis, 48093
        • Suspendu
        • Macomb Hematology Oncology PC
      • Warren, Michigan, États-Unis, 48093
        • Suspendu
        • Henry Ford Madison Heights Hospital - Breast
      • Warren, Michigan, États-Unis, 48093
        • Recrutement
        • Henry Ford Health Warren Hospital
        • Chercheur principal:
          • Christopher M. Reynolds
        • Contact:
      • Warren, Michigan, États-Unis, 48093
        • Recrutement
        • Henry Ford Warren Hospital - GLCMS
        • Chercheur principal:
          • Christopher M. Reynolds
        • Contact:
      • West Branch, Michigan, États-Unis, 48661
        • Suspendu
        • Saint Mary's Oncology/Hematology Associates of West Branch
      • Ypsilanti, Michigan, États-Unis, 48106
        • Recrutement
        • Huron Gastroenterology PC
        • Contact:
        • Chercheur principal:
          • Christopher M. Reynolds
      • Ypsilanti, Michigan, États-Unis, 48197
        • Recrutement
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Chercheur principal:
          • Christopher M. Reynolds
    • Minnesota
      • Rochester, Minnesota, États-Unis, 55905
        • Complété
        • Mayo Clinic in Rochester
    • Missouri
      • Ballwin, Missouri, États-Unis, 63011
        • Suspendu
        • Mercy Oncology and Hematology - Clayton-Clarkson
      • Bolivar, Missouri, États-Unis, 65613
        • Suspendu
        • Central Care Cancer Center - Bolivar
      • Branson, Missouri, États-Unis, 65616
        • Suspendu
        • Cox Cancer Center Branson
      • Cape Girardeau, Missouri, États-Unis, 63703
        • Suspendu
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, États-Unis, 63703
        • Suspendu
        • Mercy Cancer Center - Cape Girardeau
      • City of Saint Peters, Missouri, États-Unis, 63376
        • Recrutement
        • Siteman Cancer Center at Saint Peters Hospital
        • Chercheur principal:
          • Geoffrey L. Uy
        • Contact:
      • Creve Coeur, Missouri, États-Unis, 63141
        • Recrutement
        • Siteman Cancer Center at West County Hospital
        • Chercheur principal:
          • Geoffrey L. Uy
        • Contact:
      • Farmington, Missouri, États-Unis, 63640
        • Suspendu
        • Parkland Health Center - Farmington
      • Jefferson City, Missouri, États-Unis, 65109
        • Suspendu
        • MU Health Care Goldschmidt Cancer Center
      • Joplin, Missouri, États-Unis, 64804
        • Suspendu
        • Freeman Health System
      • Joplin, Missouri, États-Unis, 64804
        • Suspendu
        • Mercy Hospital Joplin
      • Rolla, Missouri, États-Unis, 65401
        • Suspendu
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, États-Unis, 65401
        • Suspendu
        • Phelps Health Delbert Day Cancer Institute
      • Saint Joseph, Missouri, États-Unis, 64506
        • Suspendu
        • Heartland Regional Medical Center
      • Sainte Genevieve, Missouri, États-Unis, 63670
        • Suspendu
        • Sainte Genevieve County Memorial Hospital
      • Springfield, Missouri, États-Unis, 65804
        • Suspendu
        • Mercy Hospital Springfield
      • Springfield, Missouri, États-Unis, 65807
        • Suspendu
        • CoxHealth South Hospital
      • St Louis, Missouri, États-Unis, 63110
        • Recrutement
        • Washington University School of Medicine
        • Chercheur principal:
          • Geoffrey L. Uy
        • Contact:
      • St Louis, Missouri, États-Unis, 63128
        • Recrutement
        • Mercy Hospital South
        • Chercheur principal:
          • Jay W. Carlson
        • Contact:
      • St Louis, Missouri, États-Unis, 63141
        • Recrutement
        • Mercy Hospital Saint Louis
        • Chercheur principal:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 314-251-7066
      • St Louis, Missouri, États-Unis, 63129
        • Recrutement
        • Siteman Cancer Center-South County
        • Chercheur principal:
          • Geoffrey L. Uy
        • Contact:
      • St Louis, Missouri, États-Unis, 63136
        • Recrutement
        • Siteman Cancer Center at Christian Hospital
        • Chercheur principal:
          • Geoffrey L. Uy
        • Contact:
      • St Louis, Missouri, États-Unis, 63109
        • Suspendu
        • Mercy Infusion Center - Chippewa
      • St Louis, Missouri, États-Unis, 63131
        • Suspendu
        • Missouri Baptist Medical Center
      • Sullivan, Missouri, États-Unis, 63080
        • Suspendu
        • Missouri Baptist Sullivan Hospital
      • Washington, Missouri, États-Unis, 63090
        • Suspendu
        • Mercy Hospital Washington
    • Montana
      • Missoula, Montana, États-Unis, 59802
        • Suspendu
        • Saint Patrick Hospital - Community Hospital
    • Nebraska
      • Omaha, Nebraska, États-Unis, 68198
        • Actif, ne recrute pas
        • University of Nebraska Medical Center
      • Omaha, Nebraska, États-Unis, 68118
        • Actif, ne recrute pas
        • Nebraska Medicine-Village Pointe
    • Nevada
      • Carson City, Nevada, États-Unis, 89703
        • Suspendu
        • Carson Tahoe Regional Medical Center
      • Henderson, Nevada, États-Unis, 89052
        • Suspendu
        • Cancer and Blood Specialists-Henderson
      • Henderson, Nevada, États-Unis, 89052
        • Suspendu
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson, Nevada, États-Unis, 89052
        • Suspendu
        • Comprehensive Cancer Centers of Nevada-Horizon Ridge
      • Henderson, Nevada, États-Unis, 89052
        • Suspendu
        • Las Vegas Cancer Center-Henderson
      • Henderson, Nevada, États-Unis, 89074
        • Suspendu
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
      • Henderson, Nevada, États-Unis, 89074
        • Suspendu
        • Las Vegas Urology - Green Valley
      • Henderson, Nevada, États-Unis, 89074
        • Suspendu
        • Las Vegas Urology - Pebble
      • Henderson, Nevada, États-Unis, 89074
        • Suspendu
        • Urology Specialists of Nevada - Green Valley
      • Henderson, Nevada, États-Unis, 89074
        • Suspendu
        • Oncology Las Vegas - Henderson
      • Las Vegas, Nevada, États-Unis, 89102
        • Suspendu
        • Desert West Surgery
      • Las Vegas, Nevada, États-Unis, 89109
        • Suspendu
        • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
      • Las Vegas, Nevada, États-Unis, 89113
        • Suspendu
        • HealthCare Partners Medical Group Oncology/Hematology-San Martin
      • Las Vegas, Nevada, États-Unis, 89128
        • Suspendu
        • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
      • Las Vegas, Nevada, États-Unis, 89149
        • Suspendu
        • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
      • Las Vegas, Nevada, États-Unis, 89074
        • Suspendu
        • Las Vegas Urology - Pecos
      • Las Vegas, Nevada, États-Unis, 89102
        • Suspendu
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, États-Unis, 89103
        • Suspendu
        • Hope Cancer Care of Nevada
      • Las Vegas, Nevada, États-Unis, 89106
        • Suspendu
        • Radiation Oncology Centers of Nevada Central
      • Las Vegas, Nevada, États-Unis, 89106
        • Suspendu
        • Urology Specialists of Nevada - Central
      • Las Vegas, Nevada, États-Unis, 89109
        • Suspendu
        • Sunrise Hospital and Medical Center
      • Las Vegas, Nevada, États-Unis, 89113
        • Suspendu
        • Las Vegas Prostate Cancer Center
      • Las Vegas, Nevada, États-Unis, 89113
        • Suspendu
        • Las Vegas Urology - Sunset
      • Las Vegas, Nevada, États-Unis, 89113
        • Suspendu
        • Urology Specialists of Nevada - Southwest
      • Las Vegas, Nevada, États-Unis, 89119
        • Suspendu
        • Radiation Oncology Centers of Nevada Southeast
      • Las Vegas, Nevada, États-Unis, 89128
        • Suspendu
        • Ann M Wierman MD LTD
      • Las Vegas, Nevada, États-Unis, 89128
        • Suspendu
        • Comprehensive Cancer Centers of Nevada - Northwest
      • Las Vegas, Nevada, États-Unis, 89128
        • Suspendu
        • Las Vegas Urology - Cathedral Rock
      • Las Vegas, Nevada, États-Unis, 89128
        • Suspendu
        • Las Vegas Urology - Smoke Ranch
      • Las Vegas, Nevada, États-Unis, 89128
        • Suspendu
        • OptumCare Cancer Care at MountainView
      • Las Vegas, Nevada, États-Unis, 89128
        • Suspendu
        • Urology Specialists of Nevada - Northwest
      • Las Vegas, Nevada, États-Unis, 89135
        • Suspendu
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
      • Las Vegas, Nevada, États-Unis, 89144
        • Suspendu
        • Comprehensive Cancer Centers of Nevada - Town Center
      • Las Vegas, Nevada, États-Unis, 89144
        • Suspendu
        • Comprehensive Cancer Centers of Nevada-Summerlin
      • Las Vegas, Nevada, États-Unis, 89144
        • Suspendu
        • Summerlin Hospital Medical Center
      • Las Vegas, Nevada, États-Unis, 89148-2405
        • Suspendu
        • Las Vegas Cancer Center-Medical Center
      • Las Vegas, Nevada, États-Unis, 89148
        • Suspendu
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, États-Unis, 89169
        • Suspendu
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, États-Unis, 89169
        • Suspendu
        • University Cancer Center
      • Las Vegas, Nevada, États-Unis, 89102
        • Suspendu
        • OptumCare Cancer Care at Charleston
      • Las Vegas, Nevada, États-Unis, 89128
        • Suspendu
        • Oncology Las Vegas - Tenaya
      • Las Vegas, Nevada, États-Unis, 89183
        • Suspendu
        • OptumCare Cancer Care at Fort Apache
      • Pahrump, Nevada, États-Unis, 89048
        • Suspendu
        • Hope Cancer Care of Nevada-Pahrump
      • Reno, Nevada, États-Unis, 89502
        • Suspendu
        • Renown Regional Medical Center
      • Reno, Nevada, États-Unis, 89503
        • Suspendu
        • Saint Mary's Regional Medical Center
      • Reno, Nevada, États-Unis, 89509
        • Suspendu
        • Radiation Oncology Associates
    • New York
      • Buffalo, New York, États-Unis, 14263
        • Actif, ne recrute pas
        • Roswell Park Cancer Institute
      • Lake Success, New York, États-Unis, 11042
        • Recrutement
        • Northwell Health/Center for Advanced Medicine
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 516-734-8896
        • Chercheur principal:
          • Bradley H. Goldberg
      • Manhasset, New York, États-Unis, 11030
        • Recrutement
        • North Shore University Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 516-734-8896
        • Chercheur principal:
          • Bradley H. Goldberg
      • New Hyde Park, New York, États-Unis, 11040
        • Recrutement
        • Long Island Jewish Medical Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 516-734-8896
        • Chercheur principal:
          • Bradley H. Goldberg
      • New York, New York, États-Unis, 10065
        • Actif, ne recrute pas
        • NYP/Weill Cornell Medical Center
      • Rochester, New York, États-Unis, 14642
        • Recrutement
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 585-275-5830
        • Chercheur principal:
          • Kristen M. O'Dwyer
      • Stony Brook, New York, États-Unis, 11794
        • Recrutement
        • Stony Brook University Medical Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 800-862-2215
        • Chercheur principal:
          • Suhu Liu
    • North Carolina
      • Chapel Hill, North Carolina, États-Unis, 27599
        • Suspendu
        • UNC Lineberger Comprehensive Cancer Center
      • Durham, North Carolina, États-Unis, 27710
        • Actif, ne recrute pas
        • Duke University Medical Center
      • Greenville, North Carolina, États-Unis, 27834
        • Suspendu
        • East Carolina University
      • Winston-Salem, North Carolina, États-Unis, 27157
        • Recrutement
        • Wake Forest University Health Sciences
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 336-713-6771
        • Chercheur principal:
          • Bayard L. Powell
    • Ohio
      • Cincinnati, Ohio, États-Unis, 45219
        • Recrutement
        • University of Cincinnati Cancer Center-UC Medical Center
        • Chercheur principal:
          • Emily K. Curran
        • Contact:
      • Columbus, Ohio, États-Unis, 43210
        • Recrutement
        • Ohio State University Comprehensive Cancer Center
        • Chercheur principal:
          • Gregory K. Behbehani
        • Contact:
      • West Chester, Ohio, États-Unis, 45069
        • Recrutement
        • University of Cincinnati Cancer Center-West Chester
        • Chercheur principal:
          • Emily K. Curran
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, États-Unis, 73104
        • Recrutement
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Chercheur principal:
          • Zimu Gong
      • Oklahoma City, Oklahoma, États-Unis, 73120
        • Suspendu
        • Mercy Hospital Oklahoma City
    • Oregon
      • Bend, Oregon, États-Unis, 97701
        • Suspendu
        • Saint Charles Health System
      • Clackamas, Oregon, États-Unis, 97015
        • Recrutement
        • Clackamas Radiation Oncology Center
        • Chercheur principal:
          • Alison K. Conlin
        • Contact:
      • Clackamas, Oregon, États-Unis, 97015
        • Suspendu
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, États-Unis, 97420
        • Suspendu
        • Bay Area Hospital
      • Newberg, Oregon, États-Unis, 97132
        • Recrutement
        • Providence Newberg Medical Center
        • Chercheur principal:
          • Alison K. Conlin
        • Contact:
      • Oregon City, Oregon, États-Unis, 97045
        • Recrutement
        • Providence Willamette Falls Medical Center
        • Chercheur principal:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, États-Unis, 97213
        • Recrutement
        • Providence Portland Medical Center
        • Chercheur principal:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, États-Unis, 97225
        • Recrutement
        • Providence Saint Vincent Medical Center
        • Chercheur principal:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, États-Unis, 97239
        • Actif, ne recrute pas
        • Oregon Health and Science University
      • Redmond, Oregon, États-Unis, 97756
        • Suspendu
        • Saint Charles Health System-Redmond
    • Pennsylvania
      • Allentown, Pennsylvania, États-Unis, 18103
        • Suspendu
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, États-Unis, 18017
        • Suspendu
        • Lehigh Valley Hospital - Muhlenberg
      • Chadds Ford, Pennsylvania, États-Unis, 19317
        • Suspendu
        • Christiana Care Health System-Concord Health Center
      • East Stroudsburg, Pennsylvania, États-Unis, 18301
        • Suspendu
        • Pocono Medical Center
      • Hazleton, Pennsylvania, États-Unis, 18201
        • Suspendu
        • Lehigh Valley Hospital-Hazleton
      • Philadelphia, Pennsylvania, États-Unis, 19107
        • Actif, ne recrute pas
        • Thomas Jefferson University Hospital
    • Virginia
      • Richmond, Virginia, États-Unis, 23298
        • Recrutement
        • VCU Massey Comprehensive Cancer Center
        • Chercheur principal:
          • Keri R. Maher
        • Contact:
    • Washington
      • Aberdeen, Washington, États-Unis, 98520
        • Suspendu
        • Providence Regional Cancer System-Aberdeen
      • Bellevue, Washington, États-Unis, 98004
        • Suspendu
        • Overlake Medical Center
      • Bellingham, Washington, États-Unis, 98225
        • Suspendu
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, États-Unis, 98531
        • Suspendu
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, États-Unis, 98026
        • Suspendu
        • Swedish Cancer Institute-Edmonds
      • Everett, Washington, États-Unis, 98201
        • Suspendu
        • Providence Regional Cancer Partnership
      • Issaquah, Washington, États-Unis, 98029
        • Suspendu
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, États-Unis, 99336
        • Suspendu
        • Kadlec Clinic Hematology and Oncology
      • Lacey, Washington, États-Unis, 98503
        • Suspendu
        • Providence Regional Cancer System-Lacey
      • Longview, Washington, États-Unis, 98632
        • Suspendu
        • PeaceHealth Saint John Medical Center
      • Renton, Washington, États-Unis, 98055
        • Suspendu
        • Valley Medical Center
      • Seattle, Washington, États-Unis, 98104
        • Suspendu
        • Pacific Gynecology Specialists
      • Seattle, Washington, États-Unis, 98107
        • Suspendu
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, États-Unis, 98122-5711
        • Suspendu
        • Swedish Medical Center-Cherry Hill
      • Seattle, Washington, États-Unis, 98122
        • Suspendu
        • Swedish Medical Center-First Hill
      • Sedro-Woolley, Washington, États-Unis, 98284
        • Suspendu
        • PeaceHealth United General Medical Center
      • Shelton, Washington, États-Unis, 98584
        • Suspendu
        • Providence Regional Cancer System-Shelton
      • Vancouver, Washington, États-Unis, 98664
        • Suspendu
        • PeaceHealth Southwest Medical Center
      • Walla Walla, Washington, États-Unis, 99362
        • Suspendu
        • Providence Saint Mary Regional Cancer Center
      • Yakima, Washington, États-Unis, 98902
        • Suspendu
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
      • Yelm, Washington, États-Unis, 98597
        • Suspendu
        • Providence Regional Cancer System-Yelm
    • West Virginia
      • Morgantown, West Virginia, États-Unis, 26506
        • Actif, ne recrute pas
        • West Virginia University Healthcare
    • Wisconsin
      • Eau Claire, Wisconsin, États-Unis, 54701
      • Madison, Wisconsin, États-Unis, 53792
        • Actif, ne recrute pas
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Madison, Wisconsin, États-Unis, 53718
        • Actif, ne recrute pas
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
      • Marshfield, Wisconsin, États-Unis, 54449
      • Menomonee Falls, Wisconsin, États-Unis, 53051
        • Recrutement
        • Froedtert Menomonee Falls Hospital
        • Chercheur principal:
          • Ehab L. Atallah
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 262-257-5100
      • Milwaukee, Wisconsin, États-Unis, 53226
        • Recrutement
        • Medical College of Wisconsin
        • Chercheur principal:
          • Ehab L. Atallah
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 414-805-3666
      • Minocqua, Wisconsin, États-Unis, 54548
      • New Berlin, Wisconsin, États-Unis, 53151
        • Recrutement
        • Froedtert and MCW Moorland Reserve Health Center
        • Chercheur principal:
          • Ehab L. Atallah
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 414-805-0505
      • Oak Creek, Wisconsin, États-Unis, 53154
        • Recrutement
        • Drexel Town Square Health Center
        • Chercheur principal:
          • Ehab L. Atallah
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 414-805-0505
      • Rice Lake, Wisconsin, États-Unis, 54868
      • Stevens Point, Wisconsin, États-Unis, 54482
      • West Bend, Wisconsin, États-Unis, 53095
        • Recrutement
        • Froedtert West Bend Hospital/Kraemer Cancer Center
        • Chercheur principal:
          • Ehab L. Atallah
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 414-805-0505
      • Weston, Wisconsin, États-Unis, 54476

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Cohort 1 (inotuzumab ozogamicin, blinatumomab)

See Detailed Description..
Procédure: Bone Marrow Biopsy

Undergo bone marrow biopsy

Autres noms:
  • Biopsie de la moelle osseuse
  • Biopsie, Moelle Osseuse
Biologique: Blinatumomab

Given IV

Autres noms:
  • Blincyto
  • Anticorps Monoclonal Bispécifique Anti-CD19 x Anti-CD3
  • Anticorps Monoclonal Bispécifique Recombinant Anti-CD19/Anti-CD3 MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MÉDI538
  • AMG-103
  • MÉDI 538
Procédure: Lumbar Puncture

Undergo lumbar puncture

Autres noms:
  • LP
  • Robinet rachidien
Biologique: Inotuzumab Ozogamicin

Given IV

Autres noms:
  • Sur mesure
  • CMC-544
  • Chemin 207294
  • WAY-207294
  • CMC 544
  • CMC544
Procédure: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Autres noms:
  • Collecte d'échantillons biologiques
  • Spécimen biologique collecté
  • Collecte de spécimens
  • Collection d'échantillons
Expérimental: Cohort 2 (inotuzumab ozogamicin, blinatumomab)

See Detailed Description.
Procédure: Bone Marrow Biopsy

Undergo bone marrow biopsy

Autres noms:
  • Biopsie de la moelle osseuse
  • Biopsie, Moelle Osseuse
Biologique: Blinatumomab

Given IV

Autres noms:
  • Blincyto
  • Anticorps Monoclonal Bispécifique Anti-CD19 x Anti-CD3
  • Anticorps Monoclonal Bispécifique Recombinant Anti-CD19/Anti-CD3 MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MÉDI538
  • AMG-103
  • MÉDI 538
Procédure: Bone Marrow Aspiration

Undergo bone marrow aspiration

Procédure: Lumbar Puncture

Undergo lumbar puncture

Autres noms:
  • LP
  • Robinet rachidien
Biologique: Inotuzumab Ozogamicin

Given IV

Autres noms:
  • Sur mesure
  • CMC-544
  • Chemin 207294
  • WAY-207294
  • CMC 544
  • CMC544
Procédure: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Autres noms:
  • Collecte d'échantillons biologiques
  • Spécimen biologique collecté
  • Collecte de spécimens
  • Collection d'échantillons
Expérimental: Cohort 3 (inotuzumab ozogamicin, blinatumomab, ponatinib))

See detailed description
Procédure: Bone Marrow Biopsy

Undergo bone marrow biopsy

Autres noms:
  • Biopsie de la moelle osseuse
  • Biopsie, Moelle Osseuse
Médicament: Ponatinib

Given PO

Autres noms:
  • AP-24534
  • AP24534
  • AP 24534
Biologique: Blinatumomab

Given IV

Autres noms:
  • Blincyto
  • Anticorps Monoclonal Bispécifique Anti-CD19 x Anti-CD3
  • Anticorps Monoclonal Bispécifique Recombinant Anti-CD19/Anti-CD3 MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MÉDI538
  • AMG-103
  • MÉDI 538
Procédure: Bone Marrow Aspiration

Undergo bone marrow aspiration

Procédure: Lumbar Puncture

Undergo lumbar puncture

Autres noms:
  • LP
  • Robinet rachidien
Biologique: Inotuzumab Ozogamicin

Given IV

Autres noms:
  • Sur mesure
  • CMC-544
  • Chemin 207294
  • WAY-207294
  • CMC 544
  • CMC544
Procédure: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Autres noms:
  • Collecte d'échantillons biologiques
  • Spécimen biologique collecté
  • Collecte de spécimens
  • Collection d'échantillons

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Event-free survival
Délai: 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)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Négativité minimale de la maladie résiduelle
Délai: Jusqu'à 10 ans
Jusqu'à 10 ans
Overall survival (OS)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: Up to 10 years

Point and interval estimates of the rate will be shown using a 95% binomial confidence interval.
Up to 10 years

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Rate of cytokine release syndrome (Cohort 1)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National Cancer Institute (NCI)

Les enquêteurs

  • Chercheur principal: Matthew J Wieduwilt, Alliance for Clinical Trials in Oncology

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

8 mai 2019

Achèvement primaire (Estimé)

1 février 2027

Achèvement de l'étude (Estimé)

1 février 2027

Dates d'inscription aux études

Première soumission

12 novembre 2018

Première soumission répondant aux critères de contrôle qualité

12 novembre 2018

Première publication (Réel)

14 novembre 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 novembre 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NCI-2018-02484
  • U10CA180821 (Subvention/contrat des NIH des États-Unis)
  • NCI-2018-02484 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
  • A041703 (Autre identifiant: CTEP)
  • A041703 (Autre identifiant: Alliance for Clinical Trials in Oncology)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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