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Inotuzumab Ozogamicin e Blinatumomab nel trattamento di pazienti con leucemia linfoblastica acuta di nuova diagnosi, ricorrente o refrattaria CD22 positiva di linea B

11 novembre 2026 aggiornato da: National Cancer Institute (NCI)

Uno studio di fase II su Inotuzumab Ozogamicin seguito da Blinatumomab per la leucemia linfoblastica acuta di linea B Ph-negativa CD22-positiva in anziani di nuova diagnosi o adulti con malattia recidivante o refrattaria

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.

Panoramica dello studio

Stato

Stato

Indica lo stato di reclutamento attuale o lo stato di accesso ampliato.
Reclutamento

Condizioni

Condizioni

La malattia, il disturbo, la sindrome, la malattia o la lesione oggetto di studio. Su ClinicalTrials.gov, le condizioni possono includere anche altri problemi relativi alla salute, come la durata della vita, la qualità della vita e i rischi per la salute.

Intervento / Trattamento

Intervento / Trattamento

Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.

Descrizione dettagliata

PRIMARY OBJECTIVES:

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

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

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

SECONDARY OBJECTIVES:

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

OTHER OBJECTIVE:

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

CORRELATIVE SCIENCE OBJECTIVES:

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

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

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

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

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

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

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

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

EXPLORATORY OBJECTIVES:

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

OUTLINE: Patients are assigned to 1 of 2 cohorts.

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

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

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

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

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

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

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

COHORT 3:

INDUCTION:

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

CONSOLIDATION:

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

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

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

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

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

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

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

Tipo di studio

Tipo di studio

Descrive la natura di uno studio clinico. I tipi di studio includono studi interventistici (chiamati anche studi clinici), studi osservazionali (compresi i registri dei pazienti) e accesso allargato.
Interventistico

Iscrizione (Stimato)

Iscrizione

Il numero di partecipanti a uno studio clinico. L'iscrizione "anticipata" è il numero target di partecipanti di cui i ricercatori hanno bisogno per lo studio.
84

Fase

Fase

La fase di una sperimentazione clinica che studia un farmaco o un prodotto biologico, sulla base delle definizioni sviluppate dalla Food and Drug Administration (FDA) statunitense. La fase si basa sull'obiettivo dello studio, sul numero di partecipanti e su altre caratteristiche. Ci sono cinque fasi: Early Phase 1 (precedentemente indicata come Fase 0), Phase 1, Phase 2, Phase 3 e Phase 4. Not Applicable è usato per descrivere sperimentazioni senza fasi definite dalla FDA, incluse sperimentazioni di dispositivi o interventi comportamentali.
  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Criteri di ammissibilità

I requisiti chiave che devono soddisfare le persone che vogliono partecipare a uno studio clinico o le caratteristiche che devono avere. I criteri di ammissibilità sono costituiti sia da criteri di inclusione (necessari a una persona per partecipare allo studio) sia da criteri di esclusione (che impediscono a una persona di partecipare). I tipi di criteri di ammissibilità includono se uno studio accetta volontari sani, ha requisiti di età o gruppo di età o è limitato dal sesso.

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm

Gruppo di partecipanti / Arm

Un gruppo o sottogruppo di partecipanti a uno studio clinico che riceve un intervento/trattamento specifico o nessun intervento, secondo il protocollo dello studio.
Intervento / Trattamento

Intervento / Trattamento

Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
Sperimentale: Cohort 1 (inotuzumab ozogamicin, blinatumomab)

See Detailed Description..
Procedura: Bone Marrow Biopsy

Undergo bone marrow biopsy

Altri nomi:
  • Biopsia del midollo osseo
  • Biopsia, midollo osseo
Biologico: Blinatumomab

Given IV

Altri nomi:
  • Blincyto
  • Anticorpo monoclonale bispecifico anti-CD19 x anti-CD3
  • Anticorpo monoclonale bispecifico ricombinante MT103 anti-CD19/Anti-CD3
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
Procedura: Lumbar Puncture

Undergo lumbar puncture

Altri nomi:
  • LP
  • Colpetto spinale
Biologico: Inotuzumab Ozogamicin

Given IV

Altri nomi:
  • Besponsa
  • CMC-544
  • Via 207294
  • WAY-207294
  • CMC544
Procedura: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Altri nomi:
  • Raccolta di campioni biologici
  • Biocampione raccolto
  • Raccolta di campioni
  • Raccolta campione
Sperimentale: Cohort 2 (inotuzumab ozogamicin, blinatumomab)

See Detailed Description.
Procedura: Bone Marrow Biopsy

Undergo bone marrow biopsy

Altri nomi:
  • Biopsia del midollo osseo
  • Biopsia, midollo osseo
Biologico: Blinatumomab

Given IV

Altri nomi:
  • Blincyto
  • Anticorpo monoclonale bispecifico anti-CD19 x anti-CD3
  • Anticorpo monoclonale bispecifico ricombinante MT103 anti-CD19/Anti-CD3
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
Procedura: Bone Marrow Aspiration

Undergo bone marrow aspiration

Procedura: Lumbar Puncture

Undergo lumbar puncture

Altri nomi:
  • LP
  • Colpetto spinale
Biologico: Inotuzumab Ozogamicin

Given IV

Altri nomi:
  • Besponsa
  • CMC-544
  • Via 207294
  • WAY-207294
  • CMC544
Procedura: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Altri nomi:
  • Raccolta di campioni biologici
  • Biocampione raccolto
  • Raccolta di campioni
  • Raccolta campione
Sperimentale: Cohort 3 (inotuzumab ozogamicin, blinatumomab, ponatinib))

See detailed description
Procedura: Bone Marrow Biopsy

Undergo bone marrow biopsy

Altri nomi:
  • Biopsia del midollo osseo
  • Biopsia, midollo osseo
Droga: Ponatinib

Given PO

Altri nomi:
  • AP-24534
  • AP24534
  • AP 24534
Biologico: Blinatumomab

Given IV

Altri nomi:
  • Blincyto
  • Anticorpo monoclonale bispecifico anti-CD19 x anti-CD3
  • Anticorpo monoclonale bispecifico ricombinante MT103 anti-CD19/Anti-CD3
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
Procedura: Bone Marrow Aspiration

Undergo bone marrow aspiration

Procedura: Lumbar Puncture

Undergo lumbar puncture

Altri nomi:
  • LP
  • Colpetto spinale
Biologico: Inotuzumab Ozogamicin

Given IV

Altri nomi:
  • Besponsa
  • CMC-544
  • Via 207294
  • WAY-207294
  • CMC544
Procedura: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Altri nomi:
  • Raccolta di campioni biologici
  • Biocampione raccolto
  • Raccolta di campioni
  • Raccolta campione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misure di risultato primarie

Nel protocollo di uno studio clinico, la misura dell'esito pianificato più importante per valutare l'effetto di un intervento/trattamento. La maggior parte degli studi clinici ha una misura di esito primaria, ma alcuni ne hanno più di una.
Misura del risultato
Misura Descrizione
Lasso di tempo
Event-free survival
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misure di risultato secondarie

Nel protocollo di uno studio clinico, una misura dell'esito pianificato che non è importante quanto la misura dell'esito primario per valutare l'effetto di un intervento ma è comunque di interesse. La maggior parte degli studi clinici ha più di una misura di esito secondaria.
Misura del risultato
Misura Descrizione
Lasso di tempo
Minima negatività residua di malattia
Lasso di tempo: Fino a 10 anni
Fino a 10 anni
Overall survival (OS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: Up to 10 years

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

Altre misure di risultato

Altre misure di risultato

Per gli studi clinici, una misurazione pianificata descritta nel protocollo utilizzata per determinare l'effetto di un intervento/trattamento sui partecipanti. Per gli studi osservazionali, una misurazione o un'osservazione utilizzata per descrivere modelli di malattie o tratti o associazioni con esposizioni, fattori di rischio o trattamento. I tipi di misure di esito includono la misura dell'esito primario e la misura dell'esito secondario.
Misura del risultato
Misura Descrizione
Lasso di tempo
Rate of cytokine release syndrome (Cohort 1)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sponsor

L'organizzazione o la persona che avvia lo studio e che ha autorità e controllo sullo studio.
National Cancer Institute (NCI)

Investigatori

Investigatori

Un ricercatore coinvolto in uno studio clinico. I termini correlati includono il ricercatore principale del sito, il ricercatore secondario del sito, il presidente dello studio, il direttore dello studio e il ricercatore principale dello studio.
  • Investigatore principale: Matthew J Wieduwilt, Alliance for Clinical Trials in Oncology

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

Inizio studio

La data effettiva in cui il primo partecipante è stato arruolato in uno studio clinico. La data di inizio dello studio "prevista" è la data che i ricercatori pensano sarà la data di inizio dello studio.
8 maggio 2019

Completamento primario (Stimato)

Completamento primario

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento per raccogliere i dati finali per la misura dell'esito primario. Il fatto che lo studio clinico sia terminato secondo il protocollo o sia stato interrotto non influisce su questa data. Per gli studi clinici con più di una misura di esito primario con diverse date di completamento, questo termine si riferisce alla data in cui la raccolta dei dati è completata per tutte le misure di esito primario. La data di completamento principale "prevista" è la data che i ricercatori ritengono sarà la data di completamento principale per lo studio.
1 febbraio 2027

Completamento dello studio (Stimato)

Completamento dello studio

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento/trattamento per raccogliere i dati finali per le misure di esito primarie, le misure di esito secondarie e gli eventi avversi (ovvero l'ultima visita dell'ultimo partecipante). La data di completamento dello studio "prevista" è la data che i ricercatori ritengono sarà la data di completamento dello studio.
1 febbraio 2027

Date di iscrizione allo studio

Primo inviato

Primo inviato

La data in cui lo sponsor o il ricercatore dello studio ha inviato per la prima volta un record di studio a ClinicalTrials.gov. In genere c'è un ritardo di alcuni giorni tra la prima data di invio e la disponibilità del record su ClinicalTrials.gov (la prima data di invio).
12 novembre 2018

Primo inviato che soddisfa i criteri di controllo qualità

Primo inviato che soddisfa i criteri di controllo qualità

La data in cui lo sponsor dello studio o il ricercatore invia per la prima volta un record di studio che è coerente con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). Lo sponsor o lo sperimentatore potrebbe dover rivedere e inviare un record di studio una o più volte prima che i criteri di revisione QC di NLM siano soddisfatti. È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
12 novembre 2018

Primo Inserito (Effettivo)

Primo Inserito

La data in cui il record dello studio è stato disponibile per la prima volta su ClinicalTrials.gov dopo la conclusione della revisione del controllo di qualità (QC) della National Library of Medicine (NLM). In genere c'è un ritardo di alcuni giorni tra la data in cui lo sponsor dello studio o lo sperimentatore ha presentato il record dello studio e la prima data pubblicata.
14 novembre 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento pubblicato

La data più recente in cui le modifiche al record di uno studio sono state rese disponibili su ClinicalTrials.gov. Potrebbe esserci un ritardo tra il momento in cui le modifiche sono state inviate a ClinicalTrials.gov dallo sponsor o dallo sperimentatore dello studio (data di invio dell'ultimo aggiornamento) e la data di pubblicazione dell'ultimo aggiornamento.
12 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo aggiornamento inviato che soddisfa i criteri QC

La data più recente in cui lo sponsor dello studio o il ricercatore ha presentato modifiche a un record di studio che sono coerenti con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
11 novembre 2026

Ultimo verificato

Ultimo verificato

La data più recente in cui lo sponsor dello studio o il ricercatore ha confermato che le informazioni su uno studio clinico su ClinicalTrials.gov sono accurate e aggiornate. Se uno studio con stato di reclutamento di reclutamento; non ancora reclutamento; o attivo, non reclutamento non è stato confermato negli ultimi 2 anni, lo stato di reclutamento dello studio viene mostrato come sconosciuto.
1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Altri numeri di identificazione dello studio

Identificatori o numeri ID diversi dal numero NCT assegnati a uno studio clinico dallo sponsor, dai finanziatori o da altri dello studio. Questi numeri possono includere identificatori univoci di altri registri di sperimentazione e numeri di sovvenzioni del National Institutes of Health.
  • NCI-2018-02484
  • U10CA180821 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2018-02484 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • A041703 (Altro identificatore: CTEP)
  • A041703 (Altro identificatore: Alliance for Clinical Trials in Oncology)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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