이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

새로 진단, 재발 또는 난치성 CD22 양성 B 계통 급성 림프구성 백혈병 환자 치료에 있어 이노투주맙 오조가미신 및 블리나투모맙

2026년 10월 27일 업데이트: National Cancer Institute (NCI)

새로 진단된 고령자 또는 재발성 또는 불응성 질환이 있는 성인의 Ph-음성 CD22-양성 B-계통 급성 림프구성 백혈병에 대한 이노투주맙 오조가미신에 이어 블리나투모맙의 제2상 연구

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

84

단계

  • 2 단계

연락처 및 위치

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연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Cohort 1 (inotuzumab ozogamicin, blinatumomab)

See Detailed Description..
절차: Bone Marrow Biopsy

Undergo bone marrow biopsy

다른 이름들:
  • 골수 생검
  • 생검, 골수
생물학적: Blinatumomab

Given IV

다른 이름들:
  • 블린사이토
  • 항-CD19 x 항-CD3 이중특이성 단클론항체
  • 항-CD19/항-CD3 재조합 이중특이성 단클론 항체 MT103
  • 메디-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
  • 메디 538
  • MT 103
절차: Lumbar Puncture

Undergo lumbar puncture

다른 이름들:
  • LP
  • 척추 천자
생물학적: Inotuzumab Ozogamicin

Given IV

다른 이름들:
  • 베스폰사
  • CMC-544
  • 웨이 207294
  • WAY-207294
  • CMC 544
  • CMC544
절차: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
실험적: Cohort 2 (inotuzumab ozogamicin, blinatumomab)

See Detailed Description.
절차: Bone Marrow Biopsy

Undergo bone marrow biopsy

다른 이름들:
  • 골수 생검
  • 생검, 골수
생물학적: Blinatumomab

Given IV

다른 이름들:
  • 블린사이토
  • 항-CD19 x 항-CD3 이중특이성 단클론항체
  • 항-CD19/항-CD3 재조합 이중특이성 단클론 항체 MT103
  • 메디-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
  • 메디 538
  • MT 103
절차: Bone Marrow Aspiration

Undergo bone marrow aspiration

절차: Lumbar Puncture

Undergo lumbar puncture

다른 이름들:
  • LP
  • 척추 천자
생물학적: Inotuzumab Ozogamicin

Given IV

다른 이름들:
  • 베스폰사
  • CMC-544
  • 웨이 207294
  • WAY-207294
  • CMC 544
  • CMC544
절차: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
실험적: Cohort 3 (inotuzumab ozogamicin, blinatumomab, ponatinib))

See detailed description
절차: Bone Marrow Biopsy

Undergo bone marrow biopsy

다른 이름들:
  • 골수 생검
  • 생검, 골수
의약품: Ponatinib

Given PO

다른 이름들:
  • AP-24534
  • AP24534
  • AP 24534
생물학적: Blinatumomab

Given IV

다른 이름들:
  • 블린사이토
  • 항-CD19 x 항-CD3 이중특이성 단클론항체
  • 항-CD19/항-CD3 재조합 이중특이성 단클론 항체 MT103
  • 메디-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
  • 메디 538
  • MT 103
절차: Bone Marrow Aspiration

Undergo bone marrow aspiration

절차: Lumbar Puncture

Undergo lumbar puncture

다른 이름들:
  • LP
  • 척추 천자
생물학적: Inotuzumab Ozogamicin

Given IV

다른 이름들:
  • 베스폰사
  • CMC-544
  • 웨이 207294
  • WAY-207294
  • CMC 544
  • CMC544
절차: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Event-free survival
기간: 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)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
최소 잔류 질병 음성
기간: 최대 10년
최대 10년
Overall survival (OS)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: Up to 10 years

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

기타 결과 측정

결과 측정
측정값 설명
기간
Rate of cytokine release syndrome (Cohort 1)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Cancer Institute (NCI)

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 5월 8일

기본 완료 (추정된)

2027년 2월 1일

연구 완료 (추정된)

2027년 2월 1일

연구 등록 날짜

최초 제출

2018년 11월 12일

QC 기준을 충족하는 최초 제출

2018년 11월 12일

처음 게시됨 (실제)

2018년 11월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 27일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NCI-2018-02484
  • U10CA180821 (미국 NIH 보조금/계약)
  • NCI-2018-02484 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
  • A041703 (기타 식별자: CTEP)
  • A041703 (기타 식별자: Alliance for Clinical Trials in Oncology)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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