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Inotuzumabe Ozogamicina e Blinatumomabe no Tratamento de Pacientes com Leucemia Linfoblástica Aguda Recém-diagnosticada, Recorrente ou Refratária CD22 Positiva de Linhagem B

11 de novembro de 2026 atualizado por: National Cancer Institute (NCI)

Um estudo de fase II de Inotuzumabe Ozogamicina seguido de Blinatumomabe para Ph-negativo CD22-positivo de linhagem B de leucemia linfoblástica aguda em adultos mais velhos recém-diagnosticados ou adultos com doença recidivante ou refratária

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

84

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Cohort 1 (inotuzumab ozogamicin, blinatumomab)

See Detailed Description..
Procedimento: Bone Marrow Biopsy

Undergo bone marrow biopsy

Outros nomes:
  • Biópsia de Medula Óssea
  • Biópsia, Medula Óssea
Biológico: Blinatumomab

Given IV

Outros nomes:
  • Blincyto
  • Anticorpo Monoclonal Biespecífico Anti-CD19 x Anti-CD3
  • Anticorpo Monoclonal Biespecífico Recombinante Anti-CD19/Anti-CD3 MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
  • MÉDIA 538
  • MT 103
Procedimento: Lumbar Puncture

Undergo lumbar puncture

Outros nomes:
  • LP
  • Punção lombar
Biológico: Inotuzumab Ozogamicin

Given IV

Outros nomes:
  • Besponsa
  • CMC-544
  • Caminho 207294
  • WAY-207294
  • CMC 544
  • CMC544
Procedimento: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Outros nomes:
  • Coleta de Amostras Biológicas
  • Bioespécime coletado
  • Coleta de amostras
Experimental: Cohort 2 (inotuzumab ozogamicin, blinatumomab)

See Detailed Description.
Procedimento: Bone Marrow Biopsy

Undergo bone marrow biopsy

Outros nomes:
  • Biópsia de Medula Óssea
  • Biópsia, Medula Óssea
Biológico: Blinatumomab

Given IV

Outros nomes:
  • Blincyto
  • Anticorpo Monoclonal Biespecífico Anti-CD19 x Anti-CD3
  • Anticorpo Monoclonal Biespecífico Recombinante Anti-CD19/Anti-CD3 MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
  • MÉDIA 538
  • MT 103
Procedimento: Bone Marrow Aspiration

Undergo bone marrow aspiration

Procedimento: Lumbar Puncture

Undergo lumbar puncture

Outros nomes:
  • LP
  • Punção lombar
Biológico: Inotuzumab Ozogamicin

Given IV

Outros nomes:
  • Besponsa
  • CMC-544
  • Caminho 207294
  • WAY-207294
  • CMC 544
  • CMC544
Procedimento: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Outros nomes:
  • Coleta de Amostras Biológicas
  • Bioespécime coletado
  • Coleta de amostras
Experimental: Cohort 3 (inotuzumab ozogamicin, blinatumomab, ponatinib))

See detailed description
Procedimento: Bone Marrow Biopsy

Undergo bone marrow biopsy

Outros nomes:
  • Biópsia de Medula Óssea
  • Biópsia, Medula Óssea
Medicamento: Ponatinib

Given PO

Outros nomes:
  • AP-24534
  • AP24534
  • AP 24534
Biológico: Blinatumomab

Given IV

Outros nomes:
  • Blincyto
  • Anticorpo Monoclonal Biespecífico Anti-CD19 x Anti-CD3
  • Anticorpo Monoclonal Biespecífico Recombinante Anti-CD19/Anti-CD3 MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
  • MÉDIA 538
  • MT 103
Procedimento: Bone Marrow Aspiration

Undergo bone marrow aspiration

Procedimento: Lumbar Puncture

Undergo lumbar puncture

Outros nomes:
  • LP
  • Punção lombar
Biológico: Inotuzumab Ozogamicin

Given IV

Outros nomes:
  • Besponsa
  • CMC-544
  • Caminho 207294
  • WAY-207294
  • CMC 544
  • CMC544
Procedimento: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Outros nomes:
  • Coleta de Amostras Biológicas
  • Bioespécime coletado
  • Coleta de amostras

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Event-free survival
Prazo: 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)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Negatividade residual mínima da doença
Prazo: Até 10 anos
Até 10 anos
Overall survival (OS)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: Up to 10 years

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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Rate of cytokine release syndrome (Cohort 1)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

National Cancer Institute (NCI)

Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

8 de maio de 2019

Conclusão Primária (Estimado)

1 de fevereiro de 2027

Conclusão do estudo (Estimado)

1 de fevereiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

12 de novembro de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de novembro de 2018

Primeira postagem (Real)

14 de novembro de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de novembro de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NCI-2018-02484
  • U10CA180821 (Concessão/Contrato do NIH dos EUA)
  • NCI-2018-02484 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • A041703 (Outro identificador: CTEP)
  • A041703 (Outro identificador: Alliance for Clinical Trials in Oncology)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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