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Inotuzumab Ozogamicin und Blinatumomab bei der Behandlung von Patienten mit neu diagnostizierter, rezidivierender oder refraktärer CD22-positiver akuter lymphatischer Leukämie der B-Linie

11. November 2026 aktualisiert von: National Cancer Institute (NCI)

Eine Phase-II-Studie mit Inotuzumab Ozogamicin, gefolgt von Blinatumomab, bei Ph-negativer CD22-positiver akuter lymphoblastischer Leukämie der B-Linie bei neu diagnostizierten älteren Erwachsenen oder Erwachsenen mit rezidivierter oder refraktärer Erkrankung

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

84

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Cohort 1 (inotuzumab ozogamicin, blinatumomab)

See Detailed Description..
Verfahren: Bone Marrow Biopsy

Undergo bone marrow biopsy

Andere Namen:
  • Biopsie des Knochenmarks
  • Biopsie, Knochenmark
Biologisch: Blinatumomab

Given IV

Andere Namen:
  • Blincyto
  • Bispezifischer monoklonaler Anti-CD19 x Anti-CD3-Antikörper
  • Rekombinanter bispezifischer monoklonaler Anti-CD19/Anti-CD3-Antikörper MT103
  • MEDI-538
  • MT-103
  • AMG103
  • MT103
  • MEDI538
  • AMG-103
  • MEDI 538
  • MT 103
Verfahren: Lumbar Puncture

Undergo lumbar puncture

Andere Namen:
  • LP
  • Spinalpunktion
Biologisch: Inotuzumab Ozogamicin

Given IV

Andere Namen:
  • Besponsa
  • CMC-544
  • Weg 207294
  • WEG-207294
  • CMC 544
  • CMC544
Verfahren: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Andere Namen:
  • Biologische Probensammlung
  • Bioprobe gesammelt
  • Probenentnahme
  • Beispielsammlung
Experimental: Cohort 2 (inotuzumab ozogamicin, blinatumomab)

See Detailed Description.
Verfahren: Bone Marrow Biopsy

Undergo bone marrow biopsy

Andere Namen:
  • Biopsie des Knochenmarks
  • Biopsie, Knochenmark
Biologisch: Blinatumomab

Given IV

Andere Namen:
  • Blincyto
  • Bispezifischer monoklonaler Anti-CD19 x Anti-CD3-Antikörper
  • Rekombinanter bispezifischer monoklonaler Anti-CD19/Anti-CD3-Antikörper MT103
  • MEDI-538
  • MT-103
  • AMG103
  • MT103
  • MEDI538
  • AMG-103
  • MEDI 538
  • MT 103
Verfahren: Bone Marrow Aspiration

Undergo bone marrow aspiration

Verfahren: Lumbar Puncture

Undergo lumbar puncture

Andere Namen:
  • LP
  • Spinalpunktion
Biologisch: Inotuzumab Ozogamicin

Given IV

Andere Namen:
  • Besponsa
  • CMC-544
  • Weg 207294
  • WEG-207294
  • CMC 544
  • CMC544
Verfahren: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Andere Namen:
  • Biologische Probensammlung
  • Bioprobe gesammelt
  • Probenentnahme
  • Beispielsammlung
Experimental: Cohort 3 (inotuzumab ozogamicin, blinatumomab, ponatinib))

See detailed description
Verfahren: Bone Marrow Biopsy

Undergo bone marrow biopsy

Andere Namen:
  • Biopsie des Knochenmarks
  • Biopsie, Knochenmark
Arzneimittel: Ponatinib

Given PO

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

Given IV

Andere Namen:
  • Blincyto
  • Bispezifischer monoklonaler Anti-CD19 x Anti-CD3-Antikörper
  • Rekombinanter bispezifischer monoklonaler Anti-CD19/Anti-CD3-Antikörper MT103
  • MEDI-538
  • MT-103
  • AMG103
  • MT103
  • MEDI538
  • AMG-103
  • MEDI 538
  • MT 103
Verfahren: Bone Marrow Aspiration

Undergo bone marrow aspiration

Verfahren: Lumbar Puncture

Undergo lumbar puncture

Andere Namen:
  • LP
  • Spinalpunktion
Biologisch: Inotuzumab Ozogamicin

Given IV

Andere Namen:
  • Besponsa
  • CMC-544
  • Weg 207294
  • WEG-207294
  • CMC 544
  • CMC544
Verfahren: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Andere Namen:
  • Biologische Probensammlung
  • Bioprobe gesammelt
  • Probenentnahme
  • Beispielsammlung

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Event-free survival
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Minimale verbleibende Krankheitsnegativität
Zeitfenster: Bis zu 10 Jahre
Bis zu 10 Jahre
Overall survival (OS)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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 Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Rate of cytokine release syndrome (Cohort 1)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National Cancer Institute (NCI)

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

8. Mai 2019

Primärer Abschluss (Geschätzt)

1. Februar 2027

Studienabschluss (Geschätzt)

1. Februar 2027

Studienanmeldedaten

Zuerst eingereicht

12. November 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. November 2018

Zuerst gepostet (Tatsächlich)

14. November 2018

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. November 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • NCI-2018-02484
  • U10CA180821 (US NIH Stipendium/Vertrag)
  • NCI-2018-02484 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
  • A041703 (Andere Kennung: CTEP)
  • A041703 (Andere Kennung: Alliance for Clinical Trials in Oncology)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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