Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Inotuzumab Ozogamicin og Blinatumomab i behandling av pasienter med nylig diagnostisert, tilbakevendende eller refraktær CD22-positiv B-linje Akutt lymfoblastisk leukemi

11. november 2026 oppdatert av: National Cancer Institute (NCI)

En fase II-studie av Inotuzumab Ozogamicin etterfulgt av Blinatumomab for Ph-negativ CD22-positiv B-linje akutt lymfoblastisk leukemi hos nylig diagnostisert eldre voksne eller voksne med residiverende eller refraktær sykdom

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

PRIMARY OBJECTIVES:

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

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

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

SECONDARY OBJECTIVES:

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

OTHER OBJECTIVE:

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

CORRELATIVE SCIENCE OBJECTIVES:

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

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

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

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

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

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

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

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

EXPLORATORY OBJECTIVES:

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

OUTLINE: Patients are assigned to 1 of 2 cohorts.

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

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

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

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

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

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

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

COHORT 3:

INDUCTION:

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

CONSOLIDATION:

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

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

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

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

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

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

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

Studietype

Intervensjonell

Registrering (Antatt)

84

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

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

    • Lumbar Puncture (Spinal Tap) and Intrathecal Methotrexate:

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

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

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

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

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

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

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

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

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

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

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

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

  • STEP 1: Not pregnant and not nursing.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  • COHORT 1: Age >= 60 years.

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

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

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

  • COHORT 2: Age >= 18 years.

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

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

  • COHORT 2: No isolated extramedullary relapse.

  • COHORT 2: Prior allogeneic HCT permitted.

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

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

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

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

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

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

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

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

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

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

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

  • COHORT 3: No chronic, strong CYP3A4 inducers

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cohort 1 (inotuzumab ozogamicin, blinatumomab)

See Detailed Description..
Fremgangsmåte: Bone Marrow Biopsy

Undergo bone marrow biopsy

Andre navn:
  • Biopsi av benmarg
  • Biopsi, benmarg
Biologisk: Blinatumomab

Given IV

Andre navn:
  • Blincyto
  • Anti-CD19 x Anti-CD3 bispesifikt monoklonalt antistoff
  • Anti-CD19/Anti-CD3 rekombinant bispesifikt monoklonalt antistoff MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
  • MEDI 538
  • MT 103
Fremgangsmåte: Lumbar Puncture

Undergo lumbar puncture

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

Given IV

Andre navn:
  • Besponsa
  • CMC-544
  • Vei 207294
  • WAY-207294
  • CMC 544
  • CMC544
Fremgangsmåte: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Eksperimentell: Cohort 2 (inotuzumab ozogamicin, blinatumomab)

See Detailed Description.
Fremgangsmåte: Bone Marrow Biopsy

Undergo bone marrow biopsy

Andre navn:
  • Biopsi av benmarg
  • Biopsi, benmarg
Biologisk: Blinatumomab

Given IV

Andre navn:
  • Blincyto
  • Anti-CD19 x Anti-CD3 bispesifikt monoklonalt antistoff
  • Anti-CD19/Anti-CD3 rekombinant bispesifikt monoklonalt antistoff MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
  • MEDI 538
  • MT 103
Fremgangsmåte: Bone Marrow Aspiration

Undergo bone marrow aspiration

Fremgangsmåte: Lumbar Puncture

Undergo lumbar puncture

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

Given IV

Andre navn:
  • Besponsa
  • CMC-544
  • Vei 207294
  • WAY-207294
  • CMC 544
  • CMC544
Fremgangsmåte: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Eksperimentell: Cohort 3 (inotuzumab ozogamicin, blinatumomab, ponatinib))

See detailed description
Fremgangsmåte: Bone Marrow Biopsy

Undergo bone marrow biopsy

Andre navn:
  • Biopsi av benmarg
  • Biopsi, benmarg
Legemiddel: Ponatinib

Given PO

Andre navn:
  • AP-24534
  • AP24534
  • AP 24534
Biologisk: Blinatumomab

Given IV

Andre navn:
  • Blincyto
  • Anti-CD19 x Anti-CD3 bispesifikt monoklonalt antistoff
  • Anti-CD19/Anti-CD3 rekombinant bispesifikt monoklonalt antistoff MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
  • MEDI 538
  • MT 103
Fremgangsmåte: Bone Marrow Aspiration

Undergo bone marrow aspiration

Fremgangsmåte: Lumbar Puncture

Undergo lumbar puncture

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

Given IV

Andre navn:
  • Besponsa
  • CMC-544
  • Vei 207294
  • WAY-207294
  • CMC 544
  • CMC544
Fremgangsmåte: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Event-free survival
Tidsramme: At 1 year

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

Feasibility defined as completion of the planned therapy as defined in the protocol. Success rate defined as the proportion of patients who either complete entire protocol treatment or go off protocol treatment due to the disease (e.g., refractory disease, progression, and relapse).
Up to 10 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Minimal gjenværende sykdomsnegativitet
Tidsramme: Inntil 10 år
Inntil 10 år
Overall survival (OS)
Tidsramme: Time from start of study therapy to death from any cause censored at the last known alive date, assessed up to 10 years

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

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

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

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

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

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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rate of cytokine release syndrome (Cohort 1)
Tidsramme: Up to 10 years

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

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

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

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

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

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Cancer Institute (NCI)

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

8. mai 2019

Primær fullføring (Antatt)

1. februar 2027

Studiet fullført (Antatt)

1. februar 2027

Datoer for studieregistrering

Først innsendt

12. november 2018

Først innsendt som oppfylte QC-kriteriene

12. november 2018

Først lagt ut (Faktiske)

14. november 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. november 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NCI-2018-02484
  • U10CA180821 (U.S. NIH-stipend/kontrakt)
  • NCI-2018-02484 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • A041703 (Annen identifikator: CTEP)
  • A041703 (Annen identifikator: Alliance for Clinical Trials in Oncology)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere