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Inotuzumab Ozogamicin en Blinatumomab bij de behandeling van patiënten met nieuw gediagnosticeerde, recidiverende of refractaire CD22-positieve B-lijn acute lymfoblastische leukemie

27 oktober 2026 bijgewerkt door: National Cancer Institute (NCI)

Een fase II-studie van Inotuzumab Ozogamicin gevolgd door Blinatumomab voor Ph-negatieve CD22-positieve B-lijn acute lymfoblastische leukemie bij nieuw gediagnosticeerde oudere volwassenen of volwassenen met recidiverende of refractaire ziekte

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

84

Fase

  • Fase 2

Contacten en locaties

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Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Cohort 1 (inotuzumab ozogamicin, blinatumomab)

See Detailed Description..
Procedure: Bone Marrow Biopsy

Undergo bone marrow biopsy

Andere namen:
  • Biopsie van beenmerg
  • Biopsie, beenmerg
Biologisch: Blinatumomab

Given IV

Andere namen:
  • Blincyto
  • Anti-CD19 x Anti-CD3 bispecifiek monoklonaal antilichaam
  • Anti-CD19/Anti-CD3 recombinant bispecifiek monoklonaal antilichaam MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
Procedure: Lumbar Puncture

Undergo lumbar puncture

Andere namen:
  • LP
  • Lumbaalpunctie
Biologisch: Inotuzumab Ozogamicin

Given IV

Andere namen:
  • Besponsa
  • CMC-544
  • Manier 207294
  • WEG-207294
  • CMC 544
  • CMC544
Procedure: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Andere namen:
  • Biologische monsterverzameling
  • Biospecimen verzameld
  • Specimenverzameling
  • Monsterverzameling
Experimenteel: Cohort 2 (inotuzumab ozogamicin, blinatumomab)

See Detailed Description.
Procedure: Bone Marrow Biopsy

Undergo bone marrow biopsy

Andere namen:
  • Biopsie van beenmerg
  • Biopsie, beenmerg
Biologisch: Blinatumomab

Given IV

Andere namen:
  • Blincyto
  • Anti-CD19 x Anti-CD3 bispecifiek monoklonaal antilichaam
  • Anti-CD19/Anti-CD3 recombinant bispecifiek monoklonaal antilichaam MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
Procedure: Bone Marrow Aspiration

Undergo bone marrow aspiration

Procedure: Lumbar Puncture

Undergo lumbar puncture

Andere namen:
  • LP
  • Lumbaalpunctie
Biologisch: Inotuzumab Ozogamicin

Given IV

Andere namen:
  • Besponsa
  • CMC-544
  • Manier 207294
  • WEG-207294
  • CMC 544
  • CMC544
Procedure: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Andere namen:
  • Biologische monsterverzameling
  • Biospecimen verzameld
  • Specimenverzameling
  • Monsterverzameling
Experimenteel: Cohort 3 (inotuzumab ozogamicin, blinatumomab, ponatinib))

See detailed description
Procedure: Bone Marrow Biopsy

Undergo bone marrow biopsy

Andere namen:
  • Biopsie van beenmerg
  • Biopsie, beenmerg
Geneesmiddel: Ponatinib

Given PO

Andere namen:
  • AP-24534
  • AP24534
  • AP 24534
Biologisch: Blinatumomab

Given IV

Andere namen:
  • Blincyto
  • Anti-CD19 x Anti-CD3 bispecifiek monoklonaal antilichaam
  • Anti-CD19/Anti-CD3 recombinant bispecifiek monoklonaal antilichaam MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
Procedure: Bone Marrow Aspiration

Undergo bone marrow aspiration

Procedure: Lumbar Puncture

Undergo lumbar puncture

Andere namen:
  • LP
  • Lumbaalpunctie
Biologisch: Inotuzumab Ozogamicin

Given IV

Andere namen:
  • Besponsa
  • CMC-544
  • Manier 207294
  • WEG-207294
  • CMC 544
  • CMC544
Procedure: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Andere namen:
  • Biologische monsterverzameling
  • Biospecimen verzameld
  • Specimenverzameling
  • Monsterverzameling

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Event-free survival
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Minimale residuele ziektenegativiteit
Tijdsspanne: Tot 10 jaar
Tot 10 jaar
Overall survival (OS)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: Up to 10 years

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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of cytokine release syndrome (Cohort 1)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Cancer Institute (NCI)

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

8 mei 2019

Primaire voltooiing (Geschat)

1 februari 2027

Studie voltooiing (Geschat)

1 februari 2027

Studieregistratiedata

Eerst ingediend

12 november 2018

Eerst ingediend dat voldeed aan de QC-criteria

12 november 2018

Eerst geplaatst (Werkelijk)

14 november 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

27 oktober 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NCI-2018-02484
  • U10CA180821 (Subsidie/contract van de Amerikaanse NIH)
  • NCI-2018-02484 (Register-ID: CTRP (Clinical Trial Reporting Program))
  • A041703 (Andere identificatie: CTEP)
  • A041703 (Andere identificatie: Alliance for Clinical Trials in Oncology)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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