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

이전에 치료받지 않은 맨틀 세포 림프종을 앓고 있는 고령 환자를 대상으로 연구 약물 Zanubrutinib을 사용한 연속 치료와 간헐 치료 비교 테스트

2026년 11월 2일 업데이트: Alliance for Clinical Trials in Oncology

맨틀 세포 림프종을 앓고 있는 고령 환자에서 선행 치료로 Zanubrutinib을 사용한 지속 대 간헐적 유지 요법의 무작위 3상 시험

This phase III trial tests whether continuous or intermittent zanubrutinib after achieving a complete remission (CR) with rituximab works in older adult patients with mantle cell lymphoma (MCL) who have not received treatment in the past (previously untreated). Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. When zanubrutinib is used in MCL, the current standard of care is to continue administering the drug indefinitely until disease progression. This continuous treatment comes with clinical as well as financial toxicity, which could be especially detrimental in older patients. For patients who achieve a CR after initial zanubrutinib plus rituximab therapy, it may be safe and equally effective to stop treatment and restart zanubrutinib upon disease progression rather than continuing indefinitely in previously untreated older adult patients with MCL.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

PRIMARY OBJECTIVE:

I. To compare time to first progression or death (progression free survival [PFS]1) with continuous treatment (Arm A) and time to second progression or death (PFS2) with intermittent treatment that is restarted at first progression (Arm B).

KEY SECONDARY OBJECTIVE:

I. To compare overall survival between patients who achieve a complete remission (CR) with induction therapy subsequently treated with continuous treatment versus (vs.) intermittent treatment as part of maintenance therapy.

SECONDARY OBJECTIVES:

I. To determine overall response rate (ORR) and CR rate to induction therapy with zanubrutinib and rituximab in previously untreated MCL.

II. To determine adverse events during induction and post-induction in each study arm (Arm A and B) by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

III. To determine PFS1, event free survival (EFS) and overall survival (OS) in each study arm (A and B).

IV. To determine the overall response rate (ORR) and complete response rate (CR) after restarting zanubrutinib, following the first progression, in the intermittent treatment arm (Arm B).

V. To compare burden of symptomatic adverse events (AEs) as assessed by Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) between patients randomized to Arm A versus Arm B.

QUALITY OF LIFE PRIMARY OBJECTIVE:

I. To compare health-related quality of life (QOL) at 12 months post-randomization as assessed by the Functional Assessment of Cancer Therapy (FACT) Lymphoma Symptom Index-18 (FLYMSI-18) total score between patients randomized to Arm A versus Arm B.

QUALITY OF LIFE SECONDARY OBJECTIVES:

I. To compare health-related QOL at other time points as assessed by the FLYMSI-18 total score between patients randomized to Arm A versus Arm B.

II. To compare burden of symptomatic AEs as assessed by PRO-CTCAE between patients randomized to continuous (Arm A) versus intermittent (Arm B) zanubrutinib treatment.

QUALITY OF LIFE EXPLORATORY OBJECTIVES:

I. To compare the geriatric functional and cognitive PRO as assessed by Elderly Functional Index (ELFI) and Neurology (Neuro) QOL in Arm A versus Arm B.

II. To compare cognitive function at various time points as assessed by the Neuro-QOL between patients randomized to continuous (Arm A) versus intermittent (Arm B) zanubrutinib treatment.

EXPLORATORY OBJECTIVES:

I. To evaluate the completion rate of a lymphoma-specific patient assessment of life survey (PALS) with patient directed questions on life, health, and social determinants of health (SDH) and assess the impact of the survey collected data on outcomes for all enrolled patients (study arms A and B).

II. To evaluate minimal residual disease (MRD) in those patients who achieve a CR after induction therapy (arms A and B) and how detectable MRD status changes after continued therapy vs. discontinuation of therapy (i.e. arms A vs. B).

OUTLINE:

INDUCTION THERAPY: Patients receive zanubrutinib orally (PO) twice daily (BID) on days 1-28 of each cycle and rituximab intravenously (IV) on day 1 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. . Patients undergo bone marrow biopsy and fluciclovine F18 (FDG) positron emission tomography (PET)/ computed tomography (CT) or CT throughout the trial. Patients may also undergo esophagogastroduodenoscopy (EGD) and/or colonoscopy on study as clinically indicated. Patients may optionally undergo blood sample collection throughout the trial.

MAINTENANCE THERAPY: Patients achieving a CR after induction therapy are randomized to 1 of 2 arms.

ARM A: Patients receive zanubrutinib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days until first disease progression on study. Patients undergo CT or magnetic resonance imaging (MRI) or FDG PET/CT throughout the trial. Patients may optionally undergo blood sample collection throughout the trial.

ARM B: Patients undergo observation until first disease progression and then receive zanubrutinib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days until second disease progression on study. Patients undergo CT or MRI or FDG PET/CT throughout the trial. Patients may optionally undergo blood sample collection throughout the trial and may undergo bone marrow biopsy on study.

After completion of study treatment, patients are followed within 30 days and every 6 months for 10 years.

연구 유형

중재적

등록 (추정된)

421

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • Arkansas
      • Little Rock, Arkansas, 미국, 72205
        • 모병
        • University of Arkansas for Medical Sciences
        • 연락하다:
          • Site Public Contact
          • 전화번호: 501-686-8274
        • 수석 연구원:
          • Cesar Gentille
    • California
      • Beverly Hills, California, 미국, 90211
      • Duarte, California, 미국, 91010
        • 모집하지 않고 적극적으로
        • City of Hope Comprehensive Cancer Center
      • Irvine, California, 미국, 92618
        • 모집하지 않고 적극적으로
        • City of Hope at Irvine Lennar
      • Los Angeles, California, 미국, 90048
        • 모병
        • Cedars-Sinai Medical Center
        • 수석 연구원:
          • Justin M. Darrah
        • 연락하다:
    • Connecticut
      • Derby, Connecticut, 미국, 06418
        • 모병
        • Smilow Cancer Hospital-Derby Care Center
        • 수석 연구원:
          • Shalin Kothari
        • 연락하다:
      • Fairfield, Connecticut, 미국, 06824
        • 모병
        • Smilow Cancer Hospital Care Center-Fairfield
        • 수석 연구원:
          • Shalin Kothari
        • 연락하다:
      • Glastonbury, Connecticut, 미국, 06033
        • 모병
        • Smilow Cancer Hospital Care Center at Glastonbury
        • 수석 연구원:
          • Shalin Kothari
        • 연락하다:
      • Greenwich, Connecticut, 미국, 06830
        • 모병
        • Smilow Cancer Hospital Care Center at Greenwich
        • 수석 연구원:
          • Shalin Kothari
        • 연락하다:
      • Guilford, Connecticut, 미국, 06437
        • 모병
        • Smilow Cancer Hospital Care Center - Guilford
        • 수석 연구원:
          • Shalin Kothari
        • 연락하다:
      • Hartford, Connecticut, 미국, 06105
        • 모병
        • Smilow Cancer Hospital Care Center at Saint Francis
        • 수석 연구원:
          • Shalin Kothari
        • 연락하다:
      • New Haven, Connecticut, 미국, 06520
        • 모병
        • Yale University
        • 수석 연구원:
          • Shalin Kothari
        • 연락하다:
      • North Haven, Connecticut, 미국, 06473
        • 모병
        • Yale-New Haven Hospital North Haven Medical Center
        • 수석 연구원:
          • Shalin Kothari
        • 연락하다:
      • Stamford, Connecticut, 미국, 06902
        • 모병
        • Smilow Cancer Hospital Care Center at Long Ridge
        • 수석 연구원:
          • Shalin Kothari
        • 연락하다:
      • Torrington, Connecticut, 미국, 06790
        • 모병
        • Smilow Cancer Hospital-Torrington Care Center
        • 수석 연구원:
          • Shalin Kothari
        • 연락하다:
      • Trumbull, Connecticut, 미국, 06611
        • 모병
        • Smilow Cancer Hospital Care Center-Trumbull
        • 수석 연구원:
          • Shalin Kothari
        • 연락하다:
      • Waterbury, Connecticut, 미국, 06708
        • 모병
        • Smilow Cancer Hospital-Waterbury Care Center
        • 수석 연구원:
          • Shalin Kothari
        • 연락하다:
      • Waterford, Connecticut, 미국, 06385
        • 모병
        • Smilow Cancer Hospital Care Center - Waterford
        • 수석 연구원:
          • Shalin Kothari
        • 연락하다:
    • Delaware
      • Newark, Delaware, 미국, 19713
        • 모병
        • Helen F Graham Cancer Center
        • 수석 연구원:
          • Gregory A. Masters
        • 연락하다:
      • Newark, Delaware, 미국, 19713
        • 모병
        • Medical Oncology Hematology Consultants PA
        • 수석 연구원:
          • Gregory A. Masters
        • 연락하다:
    • Georgia
      • Albany, Georgia, 미국, 31701
        • 모병
        • Phoebe Putney Memorial Hospital
        • 수석 연구원:
          • Locke J. Bryan
        • 연락하다:
      • Atlanta, Georgia, 미국, 30322
        • 모병
        • Emory University Hospital/Winship Cancer Institute
        • 연락하다:
          • Site Public Contact
          • 전화번호: 404-778-1868
        • 수석 연구원:
          • Jonathon B. Cohen
      • Atlanta, Georgia, 미국, 30303
        • 모병
        • Grady Health System
        • 연락하다:
          • Site Public Contact
          • 전화번호: 404-778-1868
        • 수석 연구원:
          • Jonathon B. Cohen
      • Atlanta, Georgia, 미국, 30308
        • 모병
        • Emory University Hospital Midtown
        • 연락하다:
          • Site Public Contact
          • 전화번호: 888-946-7447
        • 수석 연구원:
          • Jonathon B. Cohen
      • Atlanta, Georgia, 미국, 30342
        • 모병
        • Emory Saint Joseph's Hospital
        • 연락하다:
          • Site Public Contact
          • 전화번호: 404-851-7115
        • 수석 연구원:
          • Jonathon B. Cohen
      • Augusta, Georgia, 미국, 30912
        • 모병
        • Augusta University Medical Center
        • 수석 연구원:
          • Locke J. Bryan
        • 연락하다:
      • Johns Creek, Georgia, 미국, 30097
        • 모병
        • Emory Johns Creek Hospital
        • 수석 연구원:
          • Jonathon B. Cohen
        • 연락하다:
    • Idaho
      • Boise, Idaho, 미국, 83712
        • 모병
        • Saint Luke's Cancer Institute - Boise
        • 수석 연구원:
          • Alison K. Conlin
        • 연락하다:
      • Boise, Idaho, 미국, 83706
        • 모병
        • Saint Alphonsus Cancer Care Center-Boise
        • 연락하다:
        • 수석 연구원:
          • Christopher M. Reynolds
      • Caldwell, Idaho, 미국, 83605
        • 모병
        • Saint Alphonsus Cancer Care Center-Caldwell
        • 연락하다:
        • 수석 연구원:
          • Christopher M. Reynolds
      • Coeur d'Alene, Idaho, 미국, 83814
        • 모병
        • Kootenai Health - Coeur d'Alene
        • 수석 연구원:
          • John M. Schallenkamp
        • 연락하다:
      • Fruitland, Idaho, 미국, 83619
        • 모병
        • Saint Luke's Cancer Institute - Fruitland
        • 수석 연구원:
          • Alison K. Conlin
        • 연락하다:
      • Meridian, Idaho, 미국, 83642
        • 모병
        • Saint Luke's Cancer Institute - Meridian
        • 수석 연구원:
          • Alison K. Conlin
        • 연락하다:
      • Nampa, Idaho, 미국, 83687
        • 모병
        • Saint Luke's Cancer Institute - Nampa
        • 수석 연구원:
          • Alison K. Conlin
        • 연락하다:
      • Nampa, Idaho, 미국, 83687
        • 모병
        • Saint Alphonsus Cancer Care Center-Nampa
        • 연락하다:
        • 수석 연구원:
          • Christopher M. Reynolds
      • Post Falls, Idaho, 미국, 83854
        • 모병
        • Kootenai Clinic Cancer Services - Post Falls
        • 수석 연구원:
          • John M. Schallenkamp
        • 연락하다:
      • Sandpoint, Idaho, 미국, 83864
        • 모병
        • Kootenai Clinic Cancer Services - Sandpoint
        • 수석 연구원:
          • John M. Schallenkamp
        • 연락하다:
    • Illinois
      • Bloomington, Illinois, 미국, 61704
        • 모병
        • Illinois CancerCare-Bloomington
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
      • Canton, Illinois, 미국, 61520
        • 모병
        • Illinois CancerCare-Canton
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
      • Carthage, Illinois, 미국, 62321
        • 모병
        • Illinois CancerCare-Carthage
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
      • Chicago, Illinois, 미국, 60612
        • 모병
        • University of Illinois
        • 연락하다:
          • Site Public Contact
          • 전화번호: 312-355-3046
        • 수석 연구원:
          • Carlos Galvez
      • Chicago, Illinois, 미국, 60606
        • 모병
        • Alliance for Clinical Trials in Oncology
        • 수석 연구원:
          • Anne W. Beaven
        • 연락하다:
      • Danville, Illinois, 미국, 61832
        • 모병
        • Carle at The Riverfront
        • 수석 연구원:
          • Maria T. Grosse-Perdekamp
        • 연락하다:
      • Decatur, Illinois, 미국, 62526
        • 모병
        • Cancer Care Specialists of Illinois - Decatur
        • 수석 연구원:
          • Bryan A. Faller
        • 연락하다:
      • Decatur, Illinois, 미국, 62526
        • 모병
        • Decatur Memorial Hospital
        • 수석 연구원:
          • Bryan A. Faller
        • 연락하다:
      • Dixon, Illinois, 미국, 61021
        • 모병
        • Illinois CancerCare-Dixon
        • 수석 연구원:
          • Bryan A. Faller
        • 연락하다:
          • Site Public Contact
          • 전화번호: 815-285-7800
      • Effingham, Illinois, 미국, 62401
        • 모병
        • Carle Physician Group-Effingham
        • 연락하다:
        • 수석 연구원:
          • Maria T. Grosse-Perdekamp
      • Effingham, Illinois, 미국, 62401
        • 모병
        • Crossroads Cancer Center
        • 수석 연구원:
          • Bryan A. Faller
        • 연락하다:
      • Eureka, Illinois, 미국, 61530
        • 모병
        • Illinois CancerCare-Eureka
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
      • 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
        • 모병
        • Illinois CancerCare-Galesburg
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
      • 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
      • Kewanee, Illinois, 미국, 61443
        • 모병
        • Illinois CancerCare-Kewanee Clinic
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
      • Macomb, Illinois, 미국, 61455
        • 모병
        • Illinois CancerCare-Macomb
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
      • Mattoon, Illinois, 미국, 61938
        • 모병
        • Carle Physician Group-Mattoon/Charleston
        • 연락하다:
        • 수석 연구원:
          • Maria T. Grosse-Perdekamp
      • Mount Vernon, Illinois, 미국, 62864
        • 모병
        • SSM Health Good Samaritan
        • 수석 연구원:
          • Jay W. Carlson
        • 연락하다:
      • O'Fallon, Illinois, 미국, 62269
        • 모병
        • Cancer Care Center of O'Fallon
        • 수석 연구원:
          • Bryan A. Faller
        • 연락하다:
      • Ottawa, Illinois, 미국, 61350
        • 모병
        • Illinois CancerCare-Ottawa Clinic
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
      • Pekin, Illinois, 미국, 61554
        • 모병
        • Illinois CancerCare-Pekin
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
      • Peoria, Illinois, 미국, 61615
        • 모병
        • Illinois CancerCare-Peoria
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
      • Peru, Illinois, 미국, 61354
        • 모병
        • Illinois CancerCare-Peru
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
      • Princeton, Illinois, 미국, 61356
        • 모병
        • Illinois CancerCare-Princeton
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
      • Shiloh, Illinois, 미국, 62269
        • 모병
        • Memorial Hospital East
        • 연락하다:
        • 수석 연구원:
          • Brad S. Kahl
      • Springfield, Illinois, 미국, 62702
        • 모병
        • Southern Illinois University School of Medicine
        • 수석 연구원:
          • Bryan A. Faller
        • 연락하다:
          • Site Public Contact
          • 전화번호: 217-545-7929
      • Springfield, Illinois, 미국, 62702
        • 모병
        • Springfield Clinic
        • 수석 연구원:
          • Bryan A. Faller
        • 연락하다:
          • Site Public Contact
          • 전화번호: 800-444-7541
      • Springfield, Illinois, 미국, 62781
        • 모병
        • Springfield Memorial Hospital
        • 수석 연구원:
          • Bryan A. Faller
        • 연락하다:
      • Urbana, Illinois, 미국, 61801
        • 모병
        • Carle Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Maria T. Grosse-Perdekamp
      • Washington, Illinois, 미국, 61571
        • 모병
        • Illinois CancerCare - Washington
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
    • Indiana
      • Crown Point, Indiana, 미국, 46307
        • 모병
        • Northwest Cancer Center - Crown Point
        • 수석 연구원:
          • Maria T. Grosse-Perdekamp
        • 연락하다:
      • Dyer, Indiana, 미국, 46311
        • 모병
        • Northwest Oncology LLC
        • 연락하다:
          • Site Public Contact
          • 전화번호: 219-924-8178
        • 수석 연구원:
          • Maria T. Grosse-Perdekamp
      • Hobart, Indiana, 미국, 46342
        • 모병
        • Northwest Cancer Center - Hobart
        • 연락하다:
          • Site Public Contact
          • 전화번호: 219-947-1795
        • 수석 연구원:
          • Maria T. Grosse-Perdekamp
      • Hobart, Indiana, 미국, 46342
        • 모병
        • Saint Mary Medical Center
        • 수석 연구원:
          • Maria T. Grosse-Perdekamp
        • 연락하다:
      • Indianapolis, Indiana, 미국, 46312
        • 모병
        • Saint Catherine Hospital
        • 연락하다:
        • 수석 연구원:
          • Maria T. Grosse-Perdekamp
      • Munster, Indiana, 미국, 46321
        • 모병
        • The Community Hospital
        • 연락하다:
          • Site Public Contact
          • 전화번호: 219-836-3349
        • 수석 연구원:
          • Maria T. Grosse-Perdekamp
      • Munster, Indiana, 미국, 46321
        • 모병
        • Women's Diagnostic Center - Munster
        • 연락하다:
        • 수석 연구원:
          • Maria T. Grosse-Perdekamp
      • Valparaiso, Indiana, 미국, 46383
        • 모병
        • Northwest Cancer Center - Valparaiso
        • 수석 연구원:
          • Maria T. Grosse-Perdekamp
        • 연락하다:
    • Iowa
      • Ames, Iowa, 미국, 50010
        • 모병
        • Mary Greeley Medical Center
        • 수석 연구원:
          • Joseph J. Merchant
        • 연락하다:
          • Site Public Contact
          • 전화번호: 515-956-4132
      • Ames, Iowa, 미국, 50010
        • 모병
        • McFarland Clinic - Ames
        • 수석 연구원:
          • Joseph J. Merchant
        • 연락하다:
      • 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
      • Boone, Iowa, 미국, 50036
        • 정지된
        • McFarland Clinic - Boone
      • Carroll, Iowa, 미국, 51401
        • 모병
        • Saint Anthony Regional Hospital
        • 연락하다:
        • 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, 50314
        • 모병
        • Broadlawns Medical Center
        • 연락하다:
          • Site Public Contact
          • 전화번호: 515-282-2200
        • 수석 연구원:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, 미국, 50314
        • 모병
        • Mercy Medical Center - Des Moines
        • 연락하다:
          • Site Public Contact
          • 전화번호: 515-241-3305
        • 수석 연구원:
          • Richard L. Deming
      • Des Moines, Iowa, 미국, 50309
        • 모병
        • Iowa Methodist Medical Center
        • 연락하다:
          • Site Public Contact
          • 전화번호: 515-241-6727
        • 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
      • Fort Dodge, Iowa, 미국, 50501
        • 모병
        • McFarland Clinic - Trinity Cancer Center
        • 수석 연구원:
          • Joseph J. Merchant
        • 연락하다:
          • Site Public Contact
          • 전화번호: 515-956-4132
      • Fort Dodge, Iowa, 미국, 50501
        • 모병
        • UI Healthcare Mission Cancer and Blood - Fort Dodge
        • 수석 연구원:
          • Seema Harichand-Herdt
        • 연락하다:
      • Iowa City, Iowa, 미국, 52242
        • 모병
        • University of Iowa/Holden Comprehensive Cancer Center
        • 연락하다:
          • Site Public Contact
          • 전화번호: 800-237-1225
        • 수석 연구원:
          • Eric Mou
      • Jefferson, Iowa, 미국, 50129
        • 정지된
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, 미국, 50158
        • 모병
        • McFarland Clinic - Marshalltown
        • 수석 연구원:
          • Joseph J. Merchant
        • 연락하다:
          • Site Public Contact
          • 전화번호: 515-956-4132
      • 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
      • Hays, Kansas, 미국, 67601
        • 모병
        • HaysMed
        • 수석 연구원:
          • Marc S. Hoffmann
        • 연락하다:
          • Site Public Contact
          • 전화번호: 785-623-5774
      • Kansas City, Kansas, 미국, 66160
        • 모병
        • University of Kansas Cancer Center
        • 수석 연구원:
          • Marc S. Hoffmann
        • 연락하다:
      • Lawrence, Kansas, 미국, 66044
        • 모병
        • Lawrence Memorial Hospital
        • 수석 연구원:
          • Marc S. Hoffmann
        • 연락하다:
      • Leavenworth, Kansas, 미국, 66048
        • 정지된
        • Veteran Administration Eastern Kansas Healthcare
      • Olathe, Kansas, 미국, 66061
        • 모병
        • The University of Kansas Cancer Center - Olathe
        • 수석 연구원:
          • Marc S. Hoffmann
        • 연락하다:
      • Overland Park, Kansas, 미국, 66210
        • 모병
        • University of Kansas Cancer Center-Overland Park
        • 수석 연구원:
          • Marc S. Hoffmann
        • 연락하다:
      • Pittsburg, Kansas, 미국, 66762
        • 모병
        • Freeman Physician Group of Pittsburg
        • 수석 연구원:
          • Marc S. Hoffmann
        • 연락하다:
      • Salina, Kansas, 미국, 67401
        • 모병
        • Salina Regional Health Center
        • 수석 연구원:
          • Marc S. Hoffmann
        • 연락하다:
      • Topeka, Kansas, 미국, 66606
        • 모병
        • University of Kansas Health System Saint Francis Campus
        • 수석 연구원:
          • Marc S. Hoffmann
        • 연락하다:
          • Site Public Contact
          • 전화번호: 785-295-8000
      • Westwood, Kansas, 미국, 66205
        • 모병
        • University of Kansas Hospital-Westwood Cancer Center
        • 수석 연구원:
          • Marc S. Hoffmann
        • 연락하다:
    • Kentucky
      • Louisville, Kentucky, 미국, 40202
        • 모병
        • The James Graham Brown Cancer Center at University of Louisville
        • 연락하다:
          • Site Public Contact
          • 전화번호: 502-562-3429
        • 수석 연구원:
          • Hassaan Yasin
      • Louisville, Kentucky, 미국, 40245
        • 모병
        • UofL Health Medical Center Northeast
        • 연락하다:
        • 수석 연구원:
          • Hassaan Yasin
    • Michigan
      • Ann Arbor, Michigan, 미국, 48106
        • 모병
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
        • 연락하다:
        • 수석 연구원:
          • Christopher M. Reynolds
      • Bay City, Michigan, 미국, 48706
        • 모병
        • McLaren Cancer Institute-Bay City
        • 수석 연구원:
          • Dipenkumar Modi
        • 연락하다:
      • 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
      • 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
        • 모병
        • McLaren Cancer Institute-Clarkston
        • 수석 연구원:
          • Dipenkumar Modi
        • 연락하다:
      • Detroit, Michigan, 미국, 48201
        • 모병
        • Wayne State University/Karmanos Cancer Institute
        • 수석 연구원:
          • Dipenkumar Modi
        • 연락하다:
      • Farmington Hills, Michigan, 미국, 48334
        • 모병
        • Weisberg Cancer Treatment Center
        • 수석 연구원:
          • Dipenkumar Modi
        • 연락하다:
      • Farmington Hills, Michigan, 미국, 48336
        • 모병
        • Corewell Health Farmington Hills Hospital
        • 연락하다:
          • Site Public Contact
          • 전화번호: 248-551-7695
        • 수석 연구원:
          • Andrew A. Muskovitz
      • 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, 48532
        • 모병
        • McLaren Cancer Institute-Flint
        • 수석 연구원:
          • Dipenkumar Modi
        • 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:
      • Lansing, Michigan, 미국, 48912
        • 모병
        • University of Michigan Health - Sparrow Lansing
        • 수석 연구원:
          • Christopher M. Reynolds
        • 연락하다:
      • Lapeer, Michigan, 미국, 48446
        • 모병
        • McLaren Cancer Institute-Lapeer Region
        • 수석 연구원:
          • Dipenkumar Modi
        • 연락하다:
      • Livonia, Michigan, 미국, 48154
        • 모병
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • 연락하다:
        • 수석 연구원:
          • Christopher M. Reynolds
      • Macomb, Michigan, 미국, 48044
        • 모병
        • Henry Ford Saint John Hospital - Macomb Medical
        • 수석 연구원:
          • Christopher M. Reynolds
        • 연락하다:
      • Mount Pleasant, Michigan, 미국, 48858
        • 모병
        • McLaren Cancer Institute-Central Michigan
        • 수석 연구원:
          • Dipenkumar Modi
        • 연락하다:
      • Petoskey, Michigan, 미국, 49770
        • 모병
        • McLaren Cancer Institute-Northern Michigan
        • 수석 연구원:
          • Dipenkumar Modi
        • 연락하다:
      • Pontiac, Michigan, 미국, 48341
        • 모병
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • 연락하다:
        • 수석 연구원:
          • Christopher M. Reynolds
      • Royal Oak, Michigan, 미국, 48073
        • 모병
        • Corewell Health William Beaumont University Hospital
        • 연락하다:
          • Site Public Contact
          • 전화번호: 248-551-7695
        • 수석 연구원:
          • Andrew A. Muskovitz
      • 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
      • Tawas City, Michigan, 미국, 48764
      • Troy, Michigan, 미국, 48085
        • 모병
        • Corewell Health Beaumont Troy Hospital
        • 연락하다:
          • Site Public Contact
          • 전화번호: 248-551-7695
        • 수석 연구원:
          • Andrew A. Muskovitz
      • 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
      • Bemidji, Minnesota, 미국, 56601
      • Brainerd, Minnesota, 미국, 56401
        • 모병
        • Essentia Health Saint Joseph's Medical Center
        • 연락하다:
        • 수석 연구원:
          • Bret E. Friday
      • Coon Rapids, Minnesota, 미국, 55433
        • 모병
        • Mercy Hospital
        • 연락하다:
        • 수석 연구원:
          • Yan Ji
      • Deer River, Minnesota, 미국, 56636
        • 모병
        • Essentia Health - Deer River Clinic
        • 연락하다:
        • 수석 연구원:
          • Bret E. Friday
      • Duluth, Minnesota, 미국, 55805
        • 모병
        • Essentia Health Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Bret E. Friday
      • Edina, Minnesota, 미국, 55435
        • 모병
        • Minnesota Oncology - Edina
        • 연락하다:
        • 수석 연구원:
          • Yan Ji
      • Hibbing, Minnesota, 미국, 55746
        • 모병
        • Essentia Health Hibbing Clinic
        • 수석 연구원:
          • Bret E. Friday
        • 연락하다:
          • Site Public Contact
          • 전화번호: 218-786-3308
      • Maplewood, Minnesota, 미국, 55109
        • 모병
        • Saint John's Hospital - Healtheast
        • 연락하다:
        • 수석 연구원:
          • Yan Ji
      • Minneapolis, Minnesota, 미국, 55407
        • 모병
        • Abbott-Northwestern Hospital
        • 연락하다:
        • 수석 연구원:
          • Yan Ji
      • Minneapolis, Minnesota, 미국, 55415
        • 모병
        • Hennepin County Medical Center
        • 연락하다:
        • 수석 연구원:
          • Yan Ji
      • Saint Cloud, Minnesota, 미국, 56303
        • 모병
        • Coborn Cancer Center at Saint Cloud Hospital
        • 연락하다:
        • 수석 연구원:
          • Donald J. Jurgens
      • Saint Louis Park, Minnesota, 미국, 55416
        • 모병
        • Park Nicollet Clinic - Saint Louis Park
        • 연락하다:
        • 수석 연구원:
          • Yan Ji
      • Saint Paul, Minnesota, 미국, 55101
        • 모병
        • Regions Hospital
        • 연락하다:
        • 수석 연구원:
          • Yan Ji
      • Saint Paul, Minnesota, 미국, 55102
        • 모병
        • United Hospital
        • 연락하다:
        • 수석 연구원:
          • Yan Ji
      • Sandstone, Minnesota, 미국, 55072
        • 모병
        • Essentia Health Sandstone
        • 연락하다:
        • 수석 연구원:
          • Bret E. Friday
      • Virginia, Minnesota, 미국, 55792
        • 모병
        • Essentia Health Virginia Clinic
        • 연락하다:
        • 수석 연구원:
          • Bret E. Friday
      • Woodbury, Minnesota, 미국, 55125
        • 모병
        • Minnesota Oncology Hematology PA-Woodbury
        • 연락하다:
        • 수석 연구원:
          • Yan Ji
    • Missouri
      • Cape Girardeau, Missouri, 미국, 63703
        • 모병
        • Saint Francis Medical Center
        • 수석 연구원:
          • Bryan A. Faller
        • 연락하다:
          • Site Public Contact
          • 전화번호: 573-334-2230
          • 이메일: sfmc@sfmc.net
      • Chesterfield, Missouri, 미국, 63017
        • 모병
        • Saint Luke's Hospital
        • 수석 연구원:
          • Mark J. Fesler
        • 연락하다:
          • Site Public Contact
          • 전화번호: 314-205-6936
      • City of Saint Peters, Missouri, 미국, 63376
        • 모병
        • Siteman Cancer Center at Saint Peters Hospital
        • 연락하다:
        • 수석 연구원:
          • Brad S. Kahl
      • Creve Coeur, Missouri, 미국, 63141
        • 모병
        • Siteman Cancer Center at West County Hospital
        • 연락하다:
        • 수석 연구원:
          • Brad S. Kahl
      • Kansas City, Missouri, 미국, 64154
        • 모병
        • University of Kansas Cancer Center - North
        • 수석 연구원:
          • Marc S. Hoffmann
        • 연락하다:
      • Kansas City, Missouri, 미국, 64128
        • 모병
        • Kansas City Veterans Affairs Medical Center
        • 수석 연구원:
          • Suman Kambhampati
        • 연락하다:
          • Site Public Contact
          • 전화번호: 800-525-1483
      • Kansas City, Missouri, 미국, 64108
        • 모병
        • University Health Truman Medical Center
        • 수석 연구원:
          • Marc S. Hoffmann
        • 연락하다:
          • Site Public Contact
          • 전화번호: 816-404-4375
      • Kansas City, Missouri, 미국, 64116
        • 모병
        • University of Kansas Cancer Center - Briarcliff
        • 수석 연구원:
          • Marc S. Hoffmann
        • 연락하다:
          • Site Public Contact
          • 전화번호: 913-588-3671
      • Lee's Summit, Missouri, 미국, 64064
        • 모병
        • University of Kansas Cancer Center - Lee's Summit
        • 수석 연구원:
          • Marc S. Hoffmann
        • 연락하다:
      • North Kansas City, Missouri, 미국, 64116
        • 정지된
        • University of Kansas Cancer Center at North Kansas City Hospital
      • Springfield, Missouri, 미국, 65804
        • 모병
        • Mercy Hospital Springfield
        • 수석 연구원:
          • Jay W. Carlson
        • 연락하다:
          • Site Public Contact
          • 전화번호: 417-269-4520
      • Springfield, Missouri, 미국, 65807
        • 모병
        • CoxHealth South Hospital
        • 수석 연구원:
          • Jay W. Carlson
        • 연락하다:
          • Site Public Contact
          • 전화번호: 417-269-4520
      • St Louis, Missouri, 미국, 63110
        • 모병
        • Washington University School of Medicine
        • 연락하다:
        • 수석 연구원:
          • Brad S. Kahl
      • St Louis, Missouri, 미국, 63128
        • 모병
        • Mercy Hospital South
        • 수석 연구원:
          • Jay W. Carlson
        • 연락하다:
      • St Louis, Missouri, 미국, 63129
        • 모병
        • Siteman Cancer Center-South County
        • 연락하다:
        • 수석 연구원:
          • Brad S. Kahl
      • St Louis, Missouri, 미국, 63136
        • 모병
        • Siteman Cancer Center at Christian Hospital
        • 연락하다:
        • 수석 연구원:
          • Brad S. Kahl
    • Montana
      • Anaconda, Montana, 미국, 59711
        • 모병
        • Community Hospital of Anaconda
        • 수석 연구원:
          • John M. Schallenkamp
        • 연락하다:
      • Billings, Montana, 미국, 59101
        • 모병
        • Billings Clinic Cancer Center
        • 수석 연구원:
          • John M. Schallenkamp
        • 연락하다:
      • Bozeman, Montana, 미국, 59715
        • 모병
        • Bozeman Health Deaconess Hospital
        • 수석 연구원:
          • John M. Schallenkamp
        • 연락하다:
      • Great Falls, Montana, 미국, 59405
        • 모병
        • Benefis Sletten Cancer Institute
        • 수석 연구원:
          • John M. Schallenkamp
        • 연락하다:
      • Kalispell, Montana, 미국, 59901
        • 모병
        • Logan Health Medical Center
        • 수석 연구원:
          • John M. Schallenkamp
        • 연락하다:
      • Missoula, Montana, 미국, 59804
        • 모병
        • Community Medical Center
        • 수석 연구원:
          • John M. Schallenkamp
        • 연락하다:
    • Nebraska
      • Bellevue, Nebraska, 미국, 68123
        • 모병
        • Nebraska Medicine-Bellevue
        • 수석 연구원:
          • Julie M. Vose
        • 연락하다:
      • Kearney, Nebraska, 미국, 68845
        • 모병
        • Fred and Pamela Buffett Cancer Center - Kearney
        • 수석 연구원:
          • Julie M. Vose
        • 연락하다:
      • Omaha, Nebraska, 미국, 68198
        • 모병
        • University of Nebraska Medical Center
        • 수석 연구원:
          • Julie M. Vose
        • 연락하다:
      • Omaha, Nebraska, 미국, 68118
        • 모병
        • Nebraska Medicine-Village Pointe
        • 수석 연구원:
          • Julie M. Vose
        • 연락하다:
          • Site Public Contact
          • 전화번호: 402-559-5600
    • New Hampshire
      • Lebanon, New Hampshire, 미국, 03756
        • 모병
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Charles Gaulin
    • New York
      • Buffalo, New York, 미국, 14263
        • 모병
        • Roswell Park Cancer Institute
        • 연락하다:
        • 수석 연구원:
          • Chelsea Peterson
      • Camillus, New York, 미국, 13031
        • 모병
        • Hematology Oncology Associates of CNY at Camillus
        • 연락하다:
          • Site Public Contact
          • 전화번호: 315-472-7504
        • 수석 연구원:
          • Steven M. Duffy
      • East Syracuse, New York, 미국, 13057
        • 모병
        • Hematology Oncology Associates of Central New York-East Syracuse
        • 연락하다:
          • Site Public Contact
          • 전화번호: 315-472-7504
        • 수석 연구원:
          • Steven M. Duffy
      • Mineola, New York, 미국, 11501
        • 모병
        • NYU Langone Hospital - Long Island
        • 수석 연구원:
          • Peter Martin
        • 연락하다:
      • New York, New York, 미국, 10016
        • 모병
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
        • 수석 연구원:
          • Peter Martin
        • 연락하다:
      • New York, New York, 미국, 10065
        • 모병
        • NYP/Weill Cornell Medical Center
        • 수석 연구원:
          • Jia Ruan
        • 연락하다:
          • Site Public Contact
          • 전화번호: 212-746-1848
      • Rochester, New York, 미국, 14642
        • 모병
        • University of Rochester
        • 연락하다:
          • Site Public Contact
          • 전화번호: 585-275-5830
        • 수석 연구원:
          • Paul M. Barr
      • Webster, New York, 미국, 14580
    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27599
        • 모병
        • UNC Lineberger Comprehensive Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Anne W. Beaven
      • Durham, North Carolina, 미국, 27710
        • 모병
        • Duke University Medical Center
        • 연락하다:
          • Site Public Contact
          • 전화번호: 888-275-3853
        • 수석 연구원:
          • Matthew S. McKinney
    • North Dakota
      • Bismarck, North Dakota, 미국, 58501
      • Fargo, North Dakota, 미국, 58122
      • Fargo, North Dakota, 미국, 58103
        • 모병
        • Essentia Health Cancer Center-South University Clinic
        • 연락하다:
        • 수석 연구원:
          • Bret E. Friday
      • Fargo, North Dakota, 미국, 58122
    • Ohio
      • Columbus, Ohio, 미국, 43210
        • 모병
        • Ohio State University Comprehensive Cancer Center
        • 연락하다:
        • 수석 연구원:
          • David A. Bond
    • Oklahoma
      • Lawton, Oklahoma, 미국, 73505
        • 모병
        • Cancer Centers of Southwest Oklahoma Research
        • 연락하다:
          • Site Public Contact
          • 전화번호: 877-231-4440
        • 수석 연구원:
          • Taha Al-Juhaishi
      • Oklahoma City, Oklahoma, 미국, 73104
        • 모병
        • University of Oklahoma Health Sciences Center
        • 연락하다:
        • 수석 연구원:
          • Taha Al-Juhaishi
      • Tulsa, Oklahoma, 미국, 74146
        • 모병
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
        • 연락하다:
          • Site Public Contact
          • 전화번호: 918-505-3200
        • 수석 연구원:
          • Mark B. Jennings
    • Oregon
      • Newberg, Oregon, 미국, 97132
        • 모병
        • Providence Newberg Medical Center
        • 수석 연구원:
          • Alison K. Conlin
        • 연락하다:
      • Ontario, Oregon, 미국, 97914
        • 모병
        • Saint Alphonsus Cancer Care Center-Ontario
        • 연락하다:
        • 수석 연구원:
          • Christopher M. Reynolds
      • 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:
    • Rhode Island
      • Providence, Rhode Island, 미국, 02903
        • 모병
        • Rhode Island Hospital
        • 연락하다:
          • Site Public Contact
          • 전화번호: 401-444-1488
        • 수석 연구원:
          • Adam J. Olszewski
      • Westerly, Rhode Island, 미국, 02891
        • 모병
        • Smilow Cancer Hospital Care Center - Westerly
        • 수석 연구원:
          • Shalin Kothari
        • 연락하다:
    • South Carolina
      • Boiling Springs, South Carolina, 미국, 29316
        • 모병
        • Prisma Health Cancer Institute - Spartanburg
        • 수석 연구원:
          • Suzanne R. Fanning
        • 연락하다:
      • Charleston, South Carolina, 미국, 29425
        • 모병
        • Medical University of South Carolina
        • 연락하다:
        • 수석 연구원:
          • Katherine Antel
      • Easley, South Carolina, 미국, 29640
        • 모병
        • Prisma Health Cancer Institute - Easley
        • 수석 연구원:
          • Suzanne R. Fanning
        • 연락하다:
      • Greenville, South Carolina, 미국, 29605
        • 모병
        • Prisma Health Cancer Institute - Faris
        • 수석 연구원:
          • Suzanne R. Fanning
        • 연락하다:
      • Greenville, South Carolina, 미국, 29605
        • 모병
        • Prisma Health Cancer Institute - Butternut
        • 수석 연구원:
          • Suzanne R. Fanning
        • 연락하다:
      • Greenville, South Carolina, 미국, 29615
        • 모병
        • Prisma Health Cancer Institute - Eastside
        • 수석 연구원:
          • Suzanne R. Fanning
        • 연락하다:
      • Greer, South Carolina, 미국, 29650
        • 모병
        • Prisma Health Cancer Institute - Greer
        • 수석 연구원:
          • Suzanne R. Fanning
        • 연락하다:
      • Seneca, South Carolina, 미국, 29672
        • 모병
        • Prisma Health Cancer Institute - Seneca
        • 수석 연구원:
          • Suzanne R. Fanning
        • 연락하다:
    • South Dakota
      • Sioux Falls, South Dakota, 미국, 57104
      • Sioux Falls, South Dakota, 미국, 57117-5134
    • Utah
      • Salt Lake City, Utah, 미국, 84112
        • 모병
        • Huntsman Cancer Institute/University of Utah
        • 연락하다:
        • 수석 연구원:
          • Harsh Shah
    • Vermont
      • Saint Johnsbury, Vermont, 미국, 05819
        • 모병
        • Dartmouth Cancer Center - North
        • 연락하다:
        • 수석 연구원:
          • Charles Gaulin
    • Virginia
      • Richmond, Virginia, 미국, 23235
        • 모병
        • VCU Massey Cancer Center at Stony Point
        • 연락하다:
        • 수석 연구원:
          • Bruce O. Hough
      • Richmond, Virginia, 미국, 23298
        • 모병
        • VCU Massey Comprehensive Cancer Center
        • 수석 연구원:
          • Bruce O. Hough
        • 연락하다:
    • Washington
      • Edmonds, Washington, 미국, 98026
        • 모병
        • Swedish Cancer Institute-Edmonds
        • 수석 연구원:
          • Alison K. Conlin
        • 연락하다:
      • Issaquah, Washington, 미국, 98029
        • 모병
        • Swedish Cancer Institute-Issaquah
        • 수석 연구원:
          • Alison K. Conlin
        • 연락하다:
      • Seattle, Washington, 미국, 98122
        • 모병
        • Swedish Medical Center-First Hill
        • 수석 연구원:
          • Alison K. Conlin
        • 연락하다:
    • Wisconsin
      • Appleton, Wisconsin, 미국, 54911
        • 모병
        • ThedaCare Regional Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Yazhini Vallatharasu
      • Appleton, Wisconsin, 미국, 54911
        • 모병
        • ThedaCare Regional Medical Center - Appleton
        • 연락하다:
        • 수석 연구원:
          • Yazhini Vallatharasu
      • Ashland, Wisconsin, 미국, 54806
        • 모병
        • Duluth Clinic Ashland
        • 연락하다:
        • 수석 연구원:
          • Bret E. Friday
      • Eau Claire, Wisconsin, 미국, 54701
      • Johnson Creek, Wisconsin, 미국, 53038
        • 모병
        • University of Wisconsin Carbone Cancer Center - Johnson Creek
        • 수석 연구원:
          • Priyanka Pophali
        • 연락하다:
      • La Crosse, Wisconsin, 미국, 54601
        • 모병
        • Gundersen Lutheran Medical Center
        • 연락하다:
        • 수석 연구원:
          • Michael O. Ojelabi
      • Madison, Wisconsin, 미국, 53792
        • 모병
        • University of Wisconsin Carbone Cancer Center - University Hospital
        • 수석 연구원:
          • Priyanka Pophali
        • 연락하다:
      • Madison, Wisconsin, 미국, 53718
        • 모병
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
        • 수석 연구원:
          • Priyanka Pophali
        • 연락하다:
      • Marshfield, Wisconsin, 미국, 54449
      • Milwaukee, Wisconsin, 미국, 53226
        • 모병
        • Medical College of Wisconsin
        • 연락하다:
          • Site Public Contact
          • 전화번호: 414-805-3666
        • 수석 연구원:
          • Mehdi Hamadani
      • Minocqua, Wisconsin, 미국, 54548
      • Mukwonago, Wisconsin, 미국, 53149
        • 모병
        • ProHealth D N Greenwald Center
        • 연락하다:
        • 수석 연구원:
          • Timothy R. Wassenaar
      • New Berlin, Wisconsin, 미국, 53151
        • 모병
        • Froedtert and MCW Moorland Reserve Health Center
        • 연락하다:
          • Site Public Contact
          • 전화번호: 414-805-0505
        • 수석 연구원:
          • Mehdi Hamadani
      • Oconomowoc, Wisconsin, 미국, 53066
        • 모병
        • ProHealth Oconomowoc Memorial Hospital
        • 수석 연구원:
          • Timothy R. Wassenaar
        • 연락하다:
          • Site Public Contact
          • 전화번호: 262-928-7878
      • Rice Lake, Wisconsin, 미국, 54868
      • Stevens Point, Wisconsin, 미국, 54482
      • Waukesha, Wisconsin, 미국, 53188
        • 모병
        • UW Cancer Center at ProHealth Care
        • 수석 연구원:
          • Timothy R. Wassenaar
        • 연락하다:
      • Weston, Wisconsin, 미국, 54476

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

60년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • • Histologically confirmed mantle cell lymphoma with cyclin D1 (BCL1) expression by immunohistochemical stains and/or evidence of CCND1 rearrangement or t(11;14)(q13;q32) as confirmed by the enrolling center (such as by fluorescence in situ hybridization [FISH], polymerase chain reaction [PCR]/sequencing, karyotype). Patients with cyclin D1 and/or t(11;14) negative mantle cell lymphoma with an expression profile suggesting a diagnosis of mantle cell lymphoma [MCL] such as SOX11 expression are also eligible

    • Any stage allowed (stage I-IV)

      • Patient must have at least one objective measurable disease parameter by PET or CT. Measurable disease in the liver is required if the liver is the only site of lymphoma OR bone marrow involvement by MCL
      • Steroids for management of mantle cell lymphoma are allowed up to a dose of prednisone 100mg/day (or equivalent) for up to 7 days prior to registration
      • No prior systemic treatment for mantle cell lymphoma
      • No prior radiation treatment for stage I MCL
      • No prior exposure to a BTK inhibitor or anti-CD20 monoclonal antibody
      • No prior stem cell transplant
      • Age >= 70 years OR age >= 60 to < 70 years with comorbidities precluding autologous stem cell transplantation (autoSCT) including at least one of the following: a) cardiac ejection fraction (EF) <= 45%, b) diffusing capacity for carbon monoxide <= 60% predicted; c) creatinine clearance < 70 but >= 30ml/minute (min); d) Eastern Cooperative Oncology Group (ECOG) performance status of 2, which poses an unacceptable risk of toxicity for high-dose therapy and stem cell transplantation; or e) Cumulative Illness Rating Scales (CIRS) total score > 6
      • ECOG Performance Status 0-2
      • Absolute neutrophil count (ANC) >= 750/mm^3 (without growth factor support within 7 days)
      • Platelet count >= 75,000/mm^3 (or >= 50,000/mm^3 if thrombocytopenia is due to lymphoma) without growth factor support or transfusion within 7 days
      • Creatinine clearance >= 30 mL/ min determined by either: a) Estimation using the Cockcroft-Gault equation or b) Measurement by nuclear medicine scan or 24 hour urine collection
      • Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless documented Gilbert's syndrome)
      • Aspartate transferase (AST) / alanine transaminase (ALT) =< 3 x ULN
      • Patients should not be considered candidates for stem cell transplant or must have declined a stem cell transplant strategy
      • No clinically significant cardiovascular disease including the following

    • Unstable angina within 3 months before registration

    • New York Heart Association class III or IV congestive heart failure

    • History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)

    • Known QT correction formula (QTcF) > 480 msecs based on Fredericia's formula (unless pacemaker in place)

    • History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place

      • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
      • No active Hepatitis B or Hepatitis C infection. Patients with prior hepatitis B virus (HBV) exposure (positive HBV core antibody and/or surface antigen) are eligible if they have no detectable viral load, and are taking appropriate prophylactic antiviral therapy to prevent reactivation. Patients with history of hepatitis C virus (HCV) are eligible if they have an undetectable HCV viral load
      • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
      • No history of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
      • No history of stroke or intracranial hemorrhage within 6 months prior to registration
      • No disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. Patient must be able to swallow pills
      • Potential trial participants should have recovered from major surgery
      • No vaccination with a live vaccine within 35 days prior to registration
      • No hypersensitivity to zanubrutinib or rituximab or any of the other ingredients of the study drugs
      • Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study.
      • Patients on strong CYP3A4 inducers must discontinue the drug 14 days prior to registration.

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: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Induction therapy (Zanubrutinib, rituximab)

Patients receive zanubrutinib PO and rituximab IV on study. Patients undergo bone marrow biopsy and FDG PET/CT or CT throughout the trial. Patients may also undergo EDG and/or colonoscopy on study as clinically indicated. Patients may optionally undergo blood sample collection throughout the trial.
절차: Biospecimen Collection

Undergo blood sample collection

생물학적: Rituximab

Given IV

절차: Computed Tomography

Undergo CT

다른 이름들:
  • 고양이 스캔
  • CT 스캔
절차: Magnetic Resonance Imaging

Undergo MRI

다른 이름들:
  • MRI
다른: Questionnaire Administration

Ancillary studies

절차: Positron Emission Tomography

Undergo PET

다른 이름들:
  • 애완 동물
절차: Colonoscopy

Undergo colonoscopy

다른: Patient Observation

Undergo observation

절차: Esophagogastroduodenoscopy

Undergo EGD

다른 이름들:
  • EGD
의약품: Zanubrutinib

Given PO

절차: Bone Marrow Biopsy

undergo bone marrow biopsy

다른: Fludeoxyglucose F-18

Given IV
실험적: Arm A (Zanubrutinib)

Patients receive zanubrutinib PO until first disease progression on study. Patients undergo CT or MRI or FDG PET/CT throughout the trial. Patients may optionally undergo blood sample collection throughout the trial.
절차: Biospecimen Collection

Undergo blood sample collection

절차: Computed Tomography

Undergo CT

다른 이름들:
  • 고양이 스캔
  • CT 스캔
절차: Magnetic Resonance Imaging

Undergo MRI

다른 이름들:
  • MRI
다른: Questionnaire Administration

Ancillary studies

절차: Positron Emission Tomography

Undergo PET

다른 이름들:
  • 애완 동물
절차: Colonoscopy

Undergo colonoscopy

다른: Patient Observation

Undergo observation

절차: Esophagogastroduodenoscopy

Undergo EGD

다른 이름들:
  • EGD
의약품: Zanubrutinib

Given PO

절차: Bone Marrow Biopsy

undergo bone marrow biopsy

다른: Fludeoxyglucose F-18

Given IV
활성 비교기: ARM B (Observation)

Patients undergo observation until first disease progression and then receive zanubrutinib PO until second disease progression on study. Patients undergo CT or MRI or FDG PET/CT throughout the trial. Patients may optionally undergo blood sample collection throughout the trial.
절차: Biospecimen Collection

Undergo blood sample collection

절차: Computed Tomography

Undergo CT

다른 이름들:
  • 고양이 스캔
  • CT 스캔
절차: Magnetic Resonance Imaging

Undergo MRI

다른 이름들:
  • MRI
다른: Questionnaire Administration

Ancillary studies

절차: Positron Emission Tomography

Undergo PET

다른 이름들:
  • 애완 동물
절차: Colonoscopy

Undergo colonoscopy

다른: Patient Observation

Undergo observation

절차: Esophagogastroduodenoscopy

Undergo EGD

다른 이름들:
  • EGD
의약품: Zanubrutinib

Given PO

절차: Bone Marrow Biopsy

undergo bone marrow biopsy

다른: Fludeoxyglucose F-18

Given IV

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression-free survival (PFS) 1 (Arm A)
기간: Time from randomization until the earlier of first progression or death from any cause, assessed up to 10 years

Hazard ratios on the treatment effect will be estimated using a stratified cox proportional hazards model, stratified on age and mantle cell lymphoma (MCL) International Prognostic Index (IPI) score. The primary analysis for non-inferiority will be based on an intent-to-treat (ITT) analysis and will include all randomized patients in the analyses, regardless of eligibility or treatment status. Sensitivity analyses will also be done in an ancillary manner to evaluate and compare our endpoints using a modified ITT approach, and exclude from the analysis those classified as ineligible as well as those who withdraw right after randomization prior to any treatment/observation monitoring.
Time from randomization until the earlier of first progression or death from any cause, assessed up to 10 years
Progression-free survival (PFS) 2 (Arm B)
기간: Time from randomization until the earlier of second progression or death from any cause, assessed up to 10 years

Hazard ratios on the treatment effect will be estimated using a stratified cox proportional hazards model, stratified on age and MCL IPI score. The primary analysis for non-inferiority will be based on an ITT analysis and will include all randomized patients in the analyses, regardless of eligibility or treatment status. Sensitivity analyses will also be done in an ancillary manner to evaluate and compare our endpoints using a modified ITT approach, and exclude from the analysis those classified as ineligible as well as those who withdraw right after randomization prior to any treatment/observation monitoring.
Time from randomization until the earlier of second progression or death from any cause, assessed up to 10 years

2차 결과 측정

결과 측정
측정값 설명
기간
Overall survival (OS) (Arms A and B)
기간: Time from randomization until death from any cause, assessed up to 10 years

Kaplan-Meier methodology will be used to estimate the distributions of OS by treatment arm and log-rank test statistics will be used to compare these distributions between the two treatment arms. Cox Proportional Hazards models may be used to further evaluate covariates of interest with OS, including assessment of treatment effects when adjusting for other known risk factors in the model.
Time from randomization until death from any cause, assessed up to 10 years
Incidence of adverse events
기간: Up to 10 years

Will be evaluated and captured using the CTCAE 5.0, where the type and severity grade of each adverse event will be collected and tabulated within each of the treatment arms. Perceived attribution to study treatment will also be captured.

The analysis population for this secondary endpoint will include all patients who are registered and randomized on the study and receive at least one dose of study treatment. Adverse events will be monitored continuously throughout the course of the study as well as analyzed at the time of the final primary endpoint analysis.

Summary statistics and frequency tables will be used to describe the distributions of adverse events. Rates of adverse events occurring in compared across the treatment arms with chi-squared tests Tolerability will also be evaluated, summarizing rates of dose delays or modifications, reasons patients end treatment, and time to end of active treatment.
Up to 10 years
Overall response rate (ORR, complete + partial remission)
기간: up to 10 years

Will be assessed using Lugano criteria. ORR to induction is defined as the number of patients with complete or partial remission at the end of induction divided by the number of patients who receive at least one dose of the induction regimen. ORR to restart of zanubrutinib is only defined for Arm B, as the number of patients with complete or partial remission after restart of zanubrutinib divided by the number of patients that restart zanubrutinib after first disease progression following randomization. The frequencies and rates of tumor response categories will be summarized by treatment arm for response to induction as well as response to restart of zanubrutinib (Arm B only). ORR to induction and ORR to restart of zanubrutinib (Arm B only) with 95% exact binomial confidence intervals will be calculated by treatment arm. To compare the association of treatment arm and ORR to induction, chi-squared or Fisher's Exact test will be used, whichever is more appropriate at final analysis.
up to 10 years
Complete response rate (CR)
기간: Up to 10 years

Will be assessed using Lugano criteria. CR to induction is defined as the number of patients with complete remission at the end of induction divided by the number of eligible patients who receive at least one dose of the induction regimen. CR to restart of zanubrutinib is only defined for Arm B, as the number of patients with complete remission after restart of zanubrutinib divided by the number of eligible patients that restart zanubrutinib after first disease progression following randomization. CR to induction and CR to restart of zanubrutinib (Arm B patients only) with 95% exact binomial confidence intervals will be calculated by treatment arm. To compare the association of treatment arm and CR to induction, chi-squared or Fisher's Exact test will be used, whichever is more appropriate at the time of the final analysis.
Up to 10 years
Event-free survival (EFS) 1
기간: Time from randomization (Arms A and B) until the earlier of first progression, start of an alternative MCL therapy, or death from any cause, assessed up to 10 years.

For EFS1, patients without an event will be censored at the last known clinical assessment. Any patient who goes to transplant will be censored at the last known clinical assessment prior to transplant. Kaplan-Meier methodology will be used to estimate the distribution of EFS. Cox Proportional Hazards models may be used to further evaluate covariates of interest with EFS.
Time from randomization (Arms A and B) until the earlier of first progression, start of an alternative MCL therapy, or death from any cause, assessed up to 10 years.
Event-free survival (EFS) 2
기간: Time from randomization (Arm B) until the earlier of second progression, start of an alternative MCL therapy, or death from any cause, assessed up to 10 years.

For EFS2, patients without an event will be censored at the last known clinical assessment. Any patient who goes to transplant will be censored at the last known clinical assessment prior to transplant. Kaplan-Meier methodology will be used to estimate the distribution of EFS. Cox Proportional Hazards models may be used to further evaluate covariates of interest with EFS.
Time from randomization (Arm B) until the earlier of second progression, start of an alternative MCL therapy, or death from any cause, assessed up to 10 years.

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Alliance for Clinical Trials in Oncology

협력자

National Cancer Institute (NCI)

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)

2023년 10월 20일

기본 완료 (추정된)

2038년 8월 31일

연구 완료 (추정된)

2038년 8월 31일

연구 등록 날짜

최초 제출

2023년 7월 26일

QC 기준을 충족하는 최초 제출

2023년 7월 26일

처음 게시됨 (실제)

2023년 8월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • A052101
  • NCI-2023-03577 (기타 식별자: NCI Clinical Trial Reporting Program)

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미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

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