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Testen van continue versus intermitterende behandeling met het studiegeneesmiddel Zanubrutinib voor oudere patiënten met niet eerder behandeld mantelcellymfoom

2 november 2026 bijgewerkt door: Alliance for Clinical Trials in Oncology

Een gerandomiseerde fase 3-studie van continue versus intermitterende onderhoudstherapie met zanubrutinib als voorafgaande behandeling bij oudere patiënten met mantelcellymfoom

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

421

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Arkansas
      • Little Rock, Arkansas, Verenigde Staten, 72205
        • Werving
        • University of Arkansas for Medical Sciences
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 501-686-8274
        • Hoofdonderzoeker:
          • Cesar Gentille
    • California
      • Beverly Hills, California, Verenigde Staten, 90211
      • Duarte, California, Verenigde Staten, 91010
        • Actief, niet wervend
        • City of Hope Comprehensive Cancer Center
      • Irvine, California, Verenigde Staten, 92618
        • Actief, niet wervend
        • City of Hope at Irvine Lennar
      • Los Angeles, California, Verenigde Staten, 90048
        • Werving
        • Cedars-Sinai Medical Center
        • Hoofdonderzoeker:
          • Justin M. Darrah
        • Contact:
    • Connecticut
      • Derby, Connecticut, Verenigde Staten, 06418
        • Werving
        • Smilow Cancer Hospital-Derby Care Center
        • Hoofdonderzoeker:
          • Shalin Kothari
        • Contact:
      • Fairfield, Connecticut, Verenigde Staten, 06824
        • Werving
        • Smilow Cancer Hospital Care Center-Fairfield
        • Hoofdonderzoeker:
          • Shalin Kothari
        • Contact:
      • Glastonbury, Connecticut, Verenigde Staten, 06033
        • Werving
        • Smilow Cancer Hospital Care Center at Glastonbury
        • Hoofdonderzoeker:
          • Shalin Kothari
        • Contact:
      • Greenwich, Connecticut, Verenigde Staten, 06830
        • Werving
        • Smilow Cancer Hospital Care Center at Greenwich
        • Hoofdonderzoeker:
          • Shalin Kothari
        • Contact:
      • Guilford, Connecticut, Verenigde Staten, 06437
        • Werving
        • Smilow Cancer Hospital Care Center - Guilford
        • Hoofdonderzoeker:
          • Shalin Kothari
        • Contact:
      • Hartford, Connecticut, Verenigde Staten, 06105
        • Werving
        • Smilow Cancer Hospital Care Center at Saint Francis
        • Hoofdonderzoeker:
          • Shalin Kothari
        • Contact:
      • New Haven, Connecticut, Verenigde Staten, 06520
        • Werving
        • Yale University
        • Hoofdonderzoeker:
          • Shalin Kothari
        • Contact:
      • North Haven, Connecticut, Verenigde Staten, 06473
        • Werving
        • Yale-New Haven Hospital North Haven Medical Center
        • Hoofdonderzoeker:
          • Shalin Kothari
        • Contact:
      • Stamford, Connecticut, Verenigde Staten, 06902
        • Werving
        • Smilow Cancer Hospital Care Center at Long Ridge
        • Hoofdonderzoeker:
          • Shalin Kothari
        • Contact:
      • Torrington, Connecticut, Verenigde Staten, 06790
        • Werving
        • Smilow Cancer Hospital-Torrington Care Center
        • Hoofdonderzoeker:
          • Shalin Kothari
        • Contact:
      • Trumbull, Connecticut, Verenigde Staten, 06611
        • Werving
        • Smilow Cancer Hospital Care Center-Trumbull
        • Hoofdonderzoeker:
          • Shalin Kothari
        • Contact:
      • Waterbury, Connecticut, Verenigde Staten, 06708
        • Werving
        • Smilow Cancer Hospital-Waterbury Care Center
        • Hoofdonderzoeker:
          • Shalin Kothari
        • Contact:
      • Waterford, Connecticut, Verenigde Staten, 06385
        • Werving
        • Smilow Cancer Hospital Care Center - Waterford
        • Hoofdonderzoeker:
          • Shalin Kothari
        • Contact:
    • Delaware
      • Newark, Delaware, Verenigde Staten, 19713
        • Werving
        • Helen F Graham Cancer Center
        • Hoofdonderzoeker:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, Verenigde Staten, 19713
        • Werving
        • Medical Oncology Hematology Consultants PA
        • Hoofdonderzoeker:
          • Gregory A. Masters
        • Contact:
    • Georgia
      • Albany, Georgia, Verenigde Staten, 31701
        • Werving
        • Phoebe Putney Memorial Hospital
        • Hoofdonderzoeker:
          • Locke J. Bryan
        • Contact:
      • Atlanta, Georgia, Verenigde Staten, 30322
        • Werving
        • Emory University Hospital/Winship Cancer Institute
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 404-778-1868
        • Hoofdonderzoeker:
          • Jonathon B. Cohen
      • Atlanta, Georgia, Verenigde Staten, 30303
        • Werving
        • Grady Health System
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 404-778-1868
        • Hoofdonderzoeker:
          • Jonathon B. Cohen
      • Atlanta, Georgia, Verenigde Staten, 30308
        • Werving
        • Emory University Hospital Midtown
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 888-946-7447
        • Hoofdonderzoeker:
          • Jonathon B. Cohen
      • Atlanta, Georgia, Verenigde Staten, 30342
        • Werving
        • Emory Saint Joseph's Hospital
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 404-851-7115
        • Hoofdonderzoeker:
          • Jonathon B. Cohen
      • Augusta, Georgia, Verenigde Staten, 30912
        • Werving
        • Augusta University Medical Center
        • Hoofdonderzoeker:
          • Locke J. Bryan
        • Contact:
      • Johns Creek, Georgia, Verenigde Staten, 30097
        • Werving
        • Emory Johns Creek Hospital
        • Hoofdonderzoeker:
          • Jonathon B. Cohen
        • Contact:
    • Idaho
      • Boise, Idaho, Verenigde Staten, 83712
        • Werving
        • Saint Luke's Cancer Institute - Boise
        • Hoofdonderzoeker:
          • Alison K. Conlin
        • Contact:
      • Boise, Idaho, Verenigde Staten, 83706
        • Werving
        • Saint Alphonsus Cancer Care Center-Boise
        • Contact:
        • Hoofdonderzoeker:
          • Christopher M. Reynolds
      • Caldwell, Idaho, Verenigde Staten, 83605
        • Werving
        • Saint Alphonsus Cancer Care Center-Caldwell
        • Contact:
        • Hoofdonderzoeker:
          • Christopher M. Reynolds
      • Coeur d'Alene, Idaho, Verenigde Staten, 83814
        • Werving
        • Kootenai Health - Coeur d'Alene
        • Hoofdonderzoeker:
          • John M. Schallenkamp
        • Contact:
      • Fruitland, Idaho, Verenigde Staten, 83619
        • Werving
        • Saint Luke's Cancer Institute - Fruitland
        • Hoofdonderzoeker:
          • Alison K. Conlin
        • Contact:
      • Meridian, Idaho, Verenigde Staten, 83642
        • Werving
        • Saint Luke's Cancer Institute - Meridian
        • Hoofdonderzoeker:
          • Alison K. Conlin
        • Contact:
      • Nampa, Idaho, Verenigde Staten, 83687
        • Werving
        • Saint Luke's Cancer Institute - Nampa
        • Hoofdonderzoeker:
          • Alison K. Conlin
        • Contact:
      • Nampa, Idaho, Verenigde Staten, 83687
        • Werving
        • Saint Alphonsus Cancer Care Center-Nampa
        • Contact:
        • Hoofdonderzoeker:
          • Christopher M. Reynolds
      • Post Falls, Idaho, Verenigde Staten, 83854
        • Werving
        • Kootenai Clinic Cancer Services - Post Falls
        • Hoofdonderzoeker:
          • John M. Schallenkamp
        • Contact:
      • Sandpoint, Idaho, Verenigde Staten, 83864
        • Werving
        • Kootenai Clinic Cancer Services - Sandpoint
        • Hoofdonderzoeker:
          • John M. Schallenkamp
        • Contact:
    • Illinois
      • Bloomington, Illinois, Verenigde Staten, 61704
        • Werving
        • Illinois CancerCare-Bloomington
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
      • Canton, Illinois, Verenigde Staten, 61520
        • Werving
        • Illinois CancerCare-Canton
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
      • Carthage, Illinois, Verenigde Staten, 62321
        • Werving
        • Illinois CancerCare-Carthage
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
      • Chicago, Illinois, Verenigde Staten, 60612
        • Werving
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 312-355-3046
        • Hoofdonderzoeker:
          • Carlos Galvez
      • Chicago, Illinois, Verenigde Staten, 60606
        • Werving
        • Alliance for Clinical Trials in Oncology
        • Hoofdonderzoeker:
          • Anne W. Beaven
        • Contact:
      • Danville, Illinois, Verenigde Staten, 61832
        • Werving
        • Carle at The Riverfront
        • Hoofdonderzoeker:
          • Maria T. Grosse-Perdekamp
        • Contact:
      • Decatur, Illinois, Verenigde Staten, 62526
        • Werving
        • Cancer Care Specialists of Illinois - Decatur
        • Hoofdonderzoeker:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, Verenigde Staten, 62526
        • Werving
        • Decatur Memorial Hospital
        • Hoofdonderzoeker:
          • Bryan A. Faller
        • Contact:
      • Dixon, Illinois, Verenigde Staten, 61021
        • Werving
        • Illinois CancerCare-Dixon
        • Hoofdonderzoeker:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 815-285-7800
      • Effingham, Illinois, Verenigde Staten, 62401
        • Werving
        • Carle Physician Group-Effingham
        • Contact:
        • Hoofdonderzoeker:
          • Maria T. Grosse-Perdekamp
      • Effingham, Illinois, Verenigde Staten, 62401
        • Werving
        • Crossroads Cancer Center
        • Hoofdonderzoeker:
          • Bryan A. Faller
        • Contact:
      • Eureka, Illinois, Verenigde Staten, 61530
        • Werving
        • Illinois CancerCare-Eureka
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
      • Evanston, Illinois, Verenigde Staten, 60201
        • Werving
        • NorthShore University HealthSystem-Evanston Hospital
        • Hoofdonderzoeker:
          • Amy Y. Wang
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 847-570-2109
      • Galesburg, Illinois, Verenigde Staten, 61401
        • Werving
        • Illinois CancerCare-Galesburg
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
      • Glenview, Illinois, Verenigde Staten, 60026
        • Werving
        • NorthShore University HealthSystem-Glenbrook Hospital
        • Hoofdonderzoeker:
          • Amy Y. Wang
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 847-570-2109
      • Highland Park, Illinois, Verenigde Staten, 60035
        • Werving
        • NorthShore University HealthSystem-Highland Park Hospital
        • Hoofdonderzoeker:
          • Amy Y. Wang
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 847-570-2109
      • Kewanee, Illinois, Verenigde Staten, 61443
        • Werving
        • Illinois CancerCare-Kewanee Clinic
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
      • Macomb, Illinois, Verenigde Staten, 61455
        • Werving
        • Illinois CancerCare-Macomb
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
      • Mattoon, Illinois, Verenigde Staten, 61938
        • Werving
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Hoofdonderzoeker:
          • Maria T. Grosse-Perdekamp
      • Mount Vernon, Illinois, Verenigde Staten, 62864
        • Werving
        • SSM Health Good Samaritan
        • Hoofdonderzoeker:
          • Jay W. Carlson
        • Contact:
      • O'Fallon, Illinois, Verenigde Staten, 62269
        • Werving
        • Cancer Care Center of O'Fallon
        • Hoofdonderzoeker:
          • Bryan A. Faller
        • Contact:
      • Ottawa, Illinois, Verenigde Staten, 61350
        • Werving
        • Illinois CancerCare-Ottawa Clinic
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
      • Pekin, Illinois, Verenigde Staten, 61554
        • Werving
        • Illinois CancerCare-Pekin
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
      • Peoria, Illinois, Verenigde Staten, 61615
        • Werving
        • Illinois CancerCare-Peoria
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
      • Peru, Illinois, Verenigde Staten, 61354
        • Werving
        • Illinois CancerCare-Peru
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
      • Princeton, Illinois, Verenigde Staten, 61356
        • Werving
        • Illinois CancerCare-Princeton
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
      • Shiloh, Illinois, Verenigde Staten, 62269
        • Werving
        • Memorial Hospital East
        • Contact:
        • Hoofdonderzoeker:
          • Brad S. Kahl
      • Springfield, Illinois, Verenigde Staten, 62702
        • Werving
        • Southern Illinois University School of Medicine
        • Hoofdonderzoeker:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 217-545-7929
      • Springfield, Illinois, Verenigde Staten, 62702
        • Werving
        • Springfield Clinic
        • Hoofdonderzoeker:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 800-444-7541
      • Springfield, Illinois, Verenigde Staten, 62781
        • Werving
        • Springfield Memorial Hospital
        • Hoofdonderzoeker:
          • Bryan A. Faller
        • Contact:
      • Urbana, Illinois, Verenigde Staten, 61801
        • Werving
        • Carle Cancer Center
        • Contact:
        • Hoofdonderzoeker:
          • Maria T. Grosse-Perdekamp
      • Washington, Illinois, Verenigde Staten, 61571
        • Werving
        • Illinois CancerCare - Washington
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
    • Indiana
      • Crown Point, Indiana, Verenigde Staten, 46307
        • Werving
        • Northwest Cancer Center - Crown Point
        • Hoofdonderzoeker:
          • Maria T. Grosse-Perdekamp
        • Contact:
      • Dyer, Indiana, Verenigde Staten, 46311
        • Werving
        • Northwest Oncology LLC
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 219-924-8178
        • Hoofdonderzoeker:
          • Maria T. Grosse-Perdekamp
      • Hobart, Indiana, Verenigde Staten, 46342
        • Werving
        • Northwest Cancer Center - Hobart
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 219-947-1795
        • Hoofdonderzoeker:
          • Maria T. Grosse-Perdekamp
      • Hobart, Indiana, Verenigde Staten, 46342
        • Werving
        • Saint Mary Medical Center
        • Hoofdonderzoeker:
          • Maria T. Grosse-Perdekamp
        • Contact:
      • Indianapolis, Indiana, Verenigde Staten, 46312
        • Werving
        • Saint Catherine Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Maria T. Grosse-Perdekamp
      • Munster, Indiana, Verenigde Staten, 46321
        • Werving
        • The Community Hospital
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 219-836-3349
        • Hoofdonderzoeker:
          • Maria T. Grosse-Perdekamp
      • Munster, Indiana, Verenigde Staten, 46321
        • Werving
        • Women's Diagnostic Center - Munster
        • Contact:
        • Hoofdonderzoeker:
          • Maria T. Grosse-Perdekamp
      • Valparaiso, Indiana, Verenigde Staten, 46383
        • Werving
        • Northwest Cancer Center - Valparaiso
        • Hoofdonderzoeker:
          • Maria T. Grosse-Perdekamp
        • Contact:
    • Iowa
      • Ames, Iowa, Verenigde Staten, 50010
        • Werving
        • Mary Greeley Medical Center
        • Hoofdonderzoeker:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 515-956-4132
      • Ames, Iowa, Verenigde Staten, 50010
        • Werving
        • McFarland Clinic - Ames
        • Hoofdonderzoeker:
          • Joseph J. Merchant
        • Contact:
      • Ankeny, Iowa, Verenigde Staten, 50023
        • Werving
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 515-241-3305
        • Hoofdonderzoeker:
          • Seema Harichand-Herdt
      • Boone, Iowa, Verenigde Staten, 50036
        • Geschorst
        • McFarland Clinic - Boone
      • Carroll, Iowa, Verenigde Staten, 51401
        • Werving
        • Saint Anthony Regional Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Seema Harichand-Herdt
      • Clive, Iowa, Verenigde Staten, 50325
        • Werving
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 515-241-3305
        • Hoofdonderzoeker:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Verenigde Staten, 50314
        • Werving
        • Broadlawns Medical Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 515-282-2200
        • Hoofdonderzoeker:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Verenigde Staten, 50314
        • Werving
        • Mercy Medical Center - Des Moines
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 515-241-3305
        • Hoofdonderzoeker:
          • Richard L. Deming
      • Des Moines, Iowa, Verenigde Staten, 50309
        • Werving
        • Iowa Methodist Medical Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 515-241-6727
        • Hoofdonderzoeker:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Verenigde Staten, 50309
        • Werving
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 515-241-3305
        • Hoofdonderzoeker:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Verenigde Staten, 50314
        • Werving
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 515-241-3305
        • Hoofdonderzoeker:
          • Seema Harichand-Herdt
      • Fort Dodge, Iowa, Verenigde Staten, 50501
        • Werving
        • McFarland Clinic - Trinity Cancer Center
        • Hoofdonderzoeker:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 515-956-4132
      • Fort Dodge, Iowa, Verenigde Staten, 50501
        • Werving
        • UI Healthcare Mission Cancer and Blood - Fort Dodge
        • Hoofdonderzoeker:
          • Seema Harichand-Herdt
        • Contact:
      • Iowa City, Iowa, Verenigde Staten, 52242
        • Werving
        • University of Iowa/Holden Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 800-237-1225
        • Hoofdonderzoeker:
          • Eric Mou
      • Jefferson, Iowa, Verenigde Staten, 50129
        • Geschorst
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, Verenigde Staten, 50158
        • Werving
        • McFarland Clinic - Marshalltown
        • Hoofdonderzoeker:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 515-956-4132
      • Waukee, Iowa, Verenigde Staten, 50263
        • Werving
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 515-241-3305
        • Hoofdonderzoeker:
          • Seema Harichand-Herdt
    • Kansas
      • Hays, Kansas, Verenigde Staten, 67601
        • Werving
        • HaysMed
        • Hoofdonderzoeker:
          • Marc S. Hoffmann
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 785-623-5774
      • Kansas City, Kansas, Verenigde Staten, 66160
        • Werving
        • University of Kansas Cancer Center
        • Hoofdonderzoeker:
          • Marc S. Hoffmann
        • Contact:
      • Lawrence, Kansas, Verenigde Staten, 66044
        • Werving
        • Lawrence Memorial Hospital
        • Hoofdonderzoeker:
          • Marc S. Hoffmann
        • Contact:
      • Leavenworth, Kansas, Verenigde Staten, 66048
        • Geschorst
        • Veteran Administration Eastern Kansas Healthcare
      • Olathe, Kansas, Verenigde Staten, 66061
        • Werving
        • The University of Kansas Cancer Center - Olathe
        • Hoofdonderzoeker:
          • Marc S. Hoffmann
        • Contact:
      • Overland Park, Kansas, Verenigde Staten, 66210
        • Werving
        • University of Kansas Cancer Center-Overland Park
        • Hoofdonderzoeker:
          • Marc S. Hoffmann
        • Contact:
      • Pittsburg, Kansas, Verenigde Staten, 66762
        • Werving
        • Freeman Physician Group of Pittsburg
        • Hoofdonderzoeker:
          • Marc S. Hoffmann
        • Contact:
      • Salina, Kansas, Verenigde Staten, 67401
        • Werving
        • Salina Regional Health Center
        • Hoofdonderzoeker:
          • Marc S. Hoffmann
        • Contact:
      • Topeka, Kansas, Verenigde Staten, 66606
        • Werving
        • University of Kansas Health System Saint Francis Campus
        • Hoofdonderzoeker:
          • Marc S. Hoffmann
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 785-295-8000
      • Westwood, Kansas, Verenigde Staten, 66205
        • Werving
        • University of Kansas Hospital-Westwood Cancer Center
        • Hoofdonderzoeker:
          • Marc S. Hoffmann
        • Contact:
    • Kentucky
      • Louisville, Kentucky, Verenigde Staten, 40202
        • Werving
        • The James Graham Brown Cancer Center at University of Louisville
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 502-562-3429
        • Hoofdonderzoeker:
          • Hassaan Yasin
      • Louisville, Kentucky, Verenigde Staten, 40245
        • Werving
        • UofL Health Medical Center Northeast
        • Contact:
        • Hoofdonderzoeker:
          • Hassaan Yasin
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48106
        • Werving
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
        • Contact:
        • Hoofdonderzoeker:
          • Christopher M. Reynolds
      • Bay City, Michigan, Verenigde Staten, 48706
        • Werving
        • McLaren Cancer Institute-Bay City
        • Hoofdonderzoeker:
          • Dipenkumar Modi
        • Contact:
      • Brighton, Michigan, Verenigde Staten, 48114
        • Werving
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Hoofdonderzoeker:
          • Christopher M. Reynolds
      • Brighton, Michigan, Verenigde Staten, 48114
        • Werving
        • Trinity Health Medical Center - Brighton
        • Contact:
        • Hoofdonderzoeker:
          • Christopher M. Reynolds
      • Canton, Michigan, Verenigde Staten, 48188
        • Werving
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contact:
        • Hoofdonderzoeker:
          • Christopher M. Reynolds
      • Canton, Michigan, Verenigde Staten, 48188
        • Werving
        • Trinity Health Medical Center - Canton
        • Contact:
        • Hoofdonderzoeker:
          • Christopher M. Reynolds
      • Chelsea, Michigan, Verenigde Staten, 48118
        • Werving
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Christopher M. Reynolds
      • Chelsea, Michigan, Verenigde Staten, 48118
      • Clarkston, Michigan, Verenigde Staten, 48346
        • Werving
        • McLaren Cancer Institute-Clarkston
        • Hoofdonderzoeker:
          • Dipenkumar Modi
        • Contact:
      • Detroit, Michigan, Verenigde Staten, 48201
        • Werving
        • Wayne State University/Karmanos Cancer Institute
        • Hoofdonderzoeker:
          • Dipenkumar Modi
        • Contact:
      • Farmington Hills, Michigan, Verenigde Staten, 48334
        • Werving
        • Weisberg Cancer Treatment Center
        • Hoofdonderzoeker:
          • Dipenkumar Modi
        • Contact:
      • Farmington Hills, Michigan, Verenigde Staten, 48336
        • Werving
        • Corewell Health Farmington Hills Hospital
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 248-551-7695
        • Hoofdonderzoeker:
          • Andrew A. Muskovitz
      • Flint, Michigan, Verenigde Staten, 48503
        • Werving
        • Genesys Hurley Cancer Institute
        • Hoofdonderzoeker:
          • Christopher M. Reynolds
        • Contact:
      • Flint, Michigan, Verenigde Staten, 48503
        • Werving
        • Hurley Medical Center
        • Hoofdonderzoeker:
          • Christopher M. Reynolds
        • Contact:
      • Flint, Michigan, Verenigde Staten, 48532
        • Werving
        • McLaren Cancer Institute-Flint
        • Hoofdonderzoeker:
          • Dipenkumar Modi
        • Contact:
      • Flint, Michigan, Verenigde Staten, 48503
        • Geschorst
        • Genesee Hematology Oncology PC
      • Flint, Michigan, Verenigde Staten, 48503
        • Werving
        • Cancer Hematology Centers - Flint
        • Hoofdonderzoeker:
          • Christopher M. Reynolds
        • Contact:
      • Lansing, Michigan, Verenigde Staten, 48912
        • Werving
        • University of Michigan Health - Sparrow Lansing
        • Hoofdonderzoeker:
          • Christopher M. Reynolds
        • Contact:
      • Lapeer, Michigan, Verenigde Staten, 48446
        • Werving
        • McLaren Cancer Institute-Lapeer Region
        • Hoofdonderzoeker:
          • Dipenkumar Modi
        • Contact:
      • Livonia, Michigan, Verenigde Staten, 48154
        • Werving
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Christopher M. Reynolds
      • Macomb, Michigan, Verenigde Staten, 48044
        • Werving
        • Henry Ford Saint John Hospital - Macomb Medical
        • Hoofdonderzoeker:
          • Christopher M. Reynolds
        • Contact:
      • Mount Pleasant, Michigan, Verenigde Staten, 48858
        • Werving
        • McLaren Cancer Institute-Central Michigan
        • Hoofdonderzoeker:
          • Dipenkumar Modi
        • Contact:
      • Petoskey, Michigan, Verenigde Staten, 49770
        • Werving
        • McLaren Cancer Institute-Northern Michigan
        • Hoofdonderzoeker:
          • Dipenkumar Modi
        • Contact:
      • Pontiac, Michigan, Verenigde Staten, 48341
        • Werving
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Christopher M. Reynolds
      • Royal Oak, Michigan, Verenigde Staten, 48073
        • Werving
        • Corewell Health William Beaumont University Hospital
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 248-551-7695
        • Hoofdonderzoeker:
          • Andrew A. Muskovitz
      • Saginaw, Michigan, Verenigde Staten, 48604
        • Geschorst
        • Oncology Hematology Associates of Saginaw Valley PC
      • Saginaw, Michigan, Verenigde Staten, 48601
      • Tawas City, Michigan, Verenigde Staten, 48764
      • Troy, Michigan, Verenigde Staten, 48085
        • Werving
        • Corewell Health Beaumont Troy Hospital
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 248-551-7695
        • Hoofdonderzoeker:
          • Andrew A. Muskovitz
      • West Branch, Michigan, Verenigde Staten, 48661
        • Geschorst
        • Saint Mary's Oncology/Hematology Associates of West Branch
      • Ypsilanti, Michigan, Verenigde Staten, 48106
      • Ypsilanti, Michigan, Verenigde Staten, 48197
        • Werving
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Hoofdonderzoeker:
          • Christopher M. Reynolds
    • Minnesota
      • Bemidji, Minnesota, Verenigde Staten, 56601
      • Brainerd, Minnesota, Verenigde Staten, 56401
        • Werving
        • Essentia Health Saint Joseph's Medical Center
        • Contact:
        • Hoofdonderzoeker:
          • Bret E. Friday
      • Coon Rapids, Minnesota, Verenigde Staten, 55433
        • Werving
        • Mercy Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Yan Ji
      • Deer River, Minnesota, Verenigde Staten, 56636
        • Werving
        • Essentia Health - Deer River Clinic
        • Contact:
        • Hoofdonderzoeker:
          • Bret E. Friday
      • Duluth, Minnesota, Verenigde Staten, 55805
        • Werving
        • Essentia Health Cancer Center
        • Contact:
        • Hoofdonderzoeker:
          • Bret E. Friday
      • Edina, Minnesota, Verenigde Staten, 55435
        • Werving
        • Minnesota Oncology - Edina
        • Contact:
        • Hoofdonderzoeker:
          • Yan Ji
      • Hibbing, Minnesota, Verenigde Staten, 55746
        • Werving
        • Essentia Health Hibbing Clinic
        • Hoofdonderzoeker:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 218-786-3308
      • Maplewood, Minnesota, Verenigde Staten, 55109
        • Werving
        • Saint John's Hospital - Healtheast
        • Contact:
        • Hoofdonderzoeker:
          • Yan Ji
      • Minneapolis, Minnesota, Verenigde Staten, 55407
        • Werving
        • Abbott-Northwestern Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Yan Ji
      • Minneapolis, Minnesota, Verenigde Staten, 55415
        • Werving
        • Hennepin County Medical Center
        • Contact:
        • Hoofdonderzoeker:
          • Yan Ji
      • Saint Cloud, Minnesota, Verenigde Staten, 56303
        • Werving
        • Coborn Cancer Center at Saint Cloud Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Donald J. Jurgens
      • Saint Louis Park, Minnesota, Verenigde Staten, 55416
        • Werving
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Hoofdonderzoeker:
          • Yan Ji
      • Saint Paul, Minnesota, Verenigde Staten, 55101
        • Werving
        • Regions Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Yan Ji
      • Saint Paul, Minnesota, Verenigde Staten, 55102
        • Werving
        • United Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Yan Ji
      • Sandstone, Minnesota, Verenigde Staten, 55072
        • Werving
        • Essentia Health Sandstone
        • Contact:
        • Hoofdonderzoeker:
          • Bret E. Friday
      • Virginia, Minnesota, Verenigde Staten, 55792
        • Werving
        • Essentia Health Virginia Clinic
        • Contact:
        • Hoofdonderzoeker:
          • Bret E. Friday
      • Woodbury, Minnesota, Verenigde Staten, 55125
        • Werving
        • Minnesota Oncology Hematology PA-Woodbury
        • Contact:
        • Hoofdonderzoeker:
          • Yan Ji
    • Missouri
      • Cape Girardeau, Missouri, Verenigde Staten, 63703
        • Werving
        • Saint Francis Medical Center
        • Hoofdonderzoeker:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 573-334-2230
          • E-mail: sfmc@sfmc.net
      • Chesterfield, Missouri, Verenigde Staten, 63017
        • Werving
        • Saint Luke's Hospital
        • Hoofdonderzoeker:
          • Mark J. Fesler
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 314-205-6936
      • City of Saint Peters, Missouri, Verenigde Staten, 63376
        • Werving
        • Siteman Cancer Center at Saint Peters Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Brad S. Kahl
      • Creve Coeur, Missouri, Verenigde Staten, 63141
        • Werving
        • Siteman Cancer Center at West County Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Brad S. Kahl
      • Kansas City, Missouri, Verenigde Staten, 64154
        • Werving
        • University of Kansas Cancer Center - North
        • Hoofdonderzoeker:
          • Marc S. Hoffmann
        • Contact:
      • Kansas City, Missouri, Verenigde Staten, 64128
        • Werving
        • Kansas City Veterans Affairs Medical Center
        • Hoofdonderzoeker:
          • Suman Kambhampati
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 800-525-1483
      • Kansas City, Missouri, Verenigde Staten, 64108
        • Werving
        • University Health Truman Medical Center
        • Hoofdonderzoeker:
          • Marc S. Hoffmann
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 816-404-4375
      • Kansas City, Missouri, Verenigde Staten, 64116
        • Werving
        • University of Kansas Cancer Center - Briarcliff
        • Hoofdonderzoeker:
          • Marc S. Hoffmann
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 913-588-3671
      • Lee's Summit, Missouri, Verenigde Staten, 64064
        • Werving
        • University of Kansas Cancer Center - Lee's Summit
        • Hoofdonderzoeker:
          • Marc S. Hoffmann
        • Contact:
      • North Kansas City, Missouri, Verenigde Staten, 64116
        • Geschorst
        • University of Kansas Cancer Center at North Kansas City Hospital
      • Springfield, Missouri, Verenigde Staten, 65804
        • Werving
        • Mercy Hospital Springfield
        • Hoofdonderzoeker:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 417-269-4520
      • Springfield, Missouri, Verenigde Staten, 65807
        • Werving
        • CoxHealth South Hospital
        • Hoofdonderzoeker:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 417-269-4520
      • St Louis, Missouri, Verenigde Staten, 63110
        • Werving
        • Washington University School of Medicine
        • Contact:
        • Hoofdonderzoeker:
          • Brad S. Kahl
      • St Louis, Missouri, Verenigde Staten, 63128
        • Werving
        • Mercy Hospital South
        • Hoofdonderzoeker:
          • Jay W. Carlson
        • Contact:
      • St Louis, Missouri, Verenigde Staten, 63129
        • Werving
        • Siteman Cancer Center-South County
        • Contact:
        • Hoofdonderzoeker:
          • Brad S. Kahl
      • St Louis, Missouri, Verenigde Staten, 63136
        • Werving
        • Siteman Cancer Center at Christian Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Brad S. Kahl
    • Montana
      • Anaconda, Montana, Verenigde Staten, 59711
        • Werving
        • Community Hospital of Anaconda
        • Hoofdonderzoeker:
          • John M. Schallenkamp
        • Contact:
      • Billings, Montana, Verenigde Staten, 59101
        • Werving
        • Billings Clinic Cancer Center
        • Hoofdonderzoeker:
          • John M. Schallenkamp
        • Contact:
      • Bozeman, Montana, Verenigde Staten, 59715
        • Werving
        • Bozeman Health Deaconess Hospital
        • Hoofdonderzoeker:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, Verenigde Staten, 59405
        • Werving
        • Benefis Sletten Cancer Institute
        • Hoofdonderzoeker:
          • John M. Schallenkamp
        • Contact:
      • Kalispell, Montana, Verenigde Staten, 59901
        • Werving
        • Logan Health Medical Center
        • Hoofdonderzoeker:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, Verenigde Staten, 59804
        • Werving
        • Community Medical Center
        • Hoofdonderzoeker:
          • John M. Schallenkamp
        • Contact:
    • Nebraska
      • Bellevue, Nebraska, Verenigde Staten, 68123
        • Werving
        • Nebraska Medicine-Bellevue
        • Hoofdonderzoeker:
          • Julie M. Vose
        • Contact:
      • Kearney, Nebraska, Verenigde Staten, 68845
        • Werving
        • Fred and Pamela Buffett Cancer Center - Kearney
        • Hoofdonderzoeker:
          • Julie M. Vose
        • Contact:
      • Omaha, Nebraska, Verenigde Staten, 68198
        • Werving
        • University of Nebraska Medical Center
        • Hoofdonderzoeker:
          • Julie M. Vose
        • Contact:
      • Omaha, Nebraska, Verenigde Staten, 68118
        • Werving
        • Nebraska Medicine-Village Pointe
        • Hoofdonderzoeker:
          • Julie M. Vose
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 402-559-5600
    • New Hampshire
      • Lebanon, New Hampshire, Verenigde Staten, 03756
        • Werving
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Contact:
        • Hoofdonderzoeker:
          • Charles Gaulin
    • New York
      • Buffalo, New York, Verenigde Staten, 14263
        • Werving
        • Roswell Park Cancer Institute
        • Contact:
        • Hoofdonderzoeker:
          • Chelsea Peterson
      • Camillus, New York, Verenigde Staten, 13031
        • Werving
        • Hematology Oncology Associates of CNY at Camillus
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 315-472-7504
        • Hoofdonderzoeker:
          • Steven M. Duffy
      • East Syracuse, New York, Verenigde Staten, 13057
        • Werving
        • Hematology Oncology Associates of Central New York-East Syracuse
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 315-472-7504
        • Hoofdonderzoeker:
          • Steven M. Duffy
      • Mineola, New York, Verenigde Staten, 11501
        • Werving
        • NYU Langone Hospital - Long Island
        • Hoofdonderzoeker:
          • Peter Martin
        • Contact:
      • New York, New York, Verenigde Staten, 10016
        • Werving
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
        • Hoofdonderzoeker:
          • Peter Martin
        • Contact:
      • New York, New York, Verenigde Staten, 10065
        • Werving
        • NYP/Weill Cornell Medical Center
        • Hoofdonderzoeker:
          • Jia Ruan
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 212-746-1848
      • Rochester, New York, Verenigde Staten, 14642
        • Werving
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 585-275-5830
        • Hoofdonderzoeker:
          • Paul M. Barr
      • Webster, New York, Verenigde Staten, 14580
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27599
        • Werving
        • UNC Lineberger Comprehensive Cancer Center
        • Contact:
        • Hoofdonderzoeker:
          • Anne W. Beaven
      • Durham, North Carolina, Verenigde Staten, 27710
        • Werving
        • Duke University Medical Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 888-275-3853
        • Hoofdonderzoeker:
          • Matthew S. McKinney
    • North Dakota
      • Bismarck, North Dakota, Verenigde Staten, 58501
      • Fargo, North Dakota, Verenigde Staten, 58122
      • Fargo, North Dakota, Verenigde Staten, 58103
        • Werving
        • Essentia Health Cancer Center-South University Clinic
        • Contact:
        • Hoofdonderzoeker:
          • Bret E. Friday
      • Fargo, North Dakota, Verenigde Staten, 58122
    • Ohio
      • Columbus, Ohio, Verenigde Staten, 43210
        • Werving
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Hoofdonderzoeker:
          • David A. Bond
    • Oklahoma
      • Lawton, Oklahoma, Verenigde Staten, 73505
        • Werving
        • Cancer Centers of Southwest Oklahoma Research
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 877-231-4440
        • Hoofdonderzoeker:
          • Taha Al-Juhaishi
      • Oklahoma City, Oklahoma, Verenigde Staten, 73104
        • Werving
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Hoofdonderzoeker:
          • Taha Al-Juhaishi
      • Tulsa, Oklahoma, Verenigde Staten, 74146
        • Werving
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 918-505-3200
        • Hoofdonderzoeker:
          • Mark B. Jennings
    • Oregon
      • Newberg, Oregon, Verenigde Staten, 97132
        • Werving
        • Providence Newberg Medical Center
        • Hoofdonderzoeker:
          • Alison K. Conlin
        • Contact:
      • Ontario, Oregon, Verenigde Staten, 97914
        • Werving
        • Saint Alphonsus Cancer Care Center-Ontario
        • Contact:
        • Hoofdonderzoeker:
          • Christopher M. Reynolds
      • Oregon City, Oregon, Verenigde Staten, 97045
        • Werving
        • Providence Willamette Falls Medical Center
        • Hoofdonderzoeker:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, Verenigde Staten, 97213
        • Werving
        • Providence Portland Medical Center
        • Hoofdonderzoeker:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, Verenigde Staten, 97225
        • Werving
        • Providence Saint Vincent Medical Center
        • Hoofdonderzoeker:
          • Alison K. Conlin
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, Verenigde Staten, 02903
        • Werving
        • Rhode Island Hospital
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 401-444-1488
        • Hoofdonderzoeker:
          • Adam J. Olszewski
      • Westerly, Rhode Island, Verenigde Staten, 02891
        • Werving
        • Smilow Cancer Hospital Care Center - Westerly
        • Hoofdonderzoeker:
          • Shalin Kothari
        • Contact:
    • South Carolina
      • Boiling Springs, South Carolina, Verenigde Staten, 29316
        • Werving
        • Prisma Health Cancer Institute - Spartanburg
        • Hoofdonderzoeker:
          • Suzanne R. Fanning
        • Contact:
      • Charleston, South Carolina, Verenigde Staten, 29425
        • Werving
        • Medical University of South Carolina
        • Contact:
        • Hoofdonderzoeker:
          • Katherine Antel
      • Easley, South Carolina, Verenigde Staten, 29640
        • Werving
        • Prisma Health Cancer Institute - Easley
        • Hoofdonderzoeker:
          • Suzanne R. Fanning
        • Contact:
      • Greenville, South Carolina, Verenigde Staten, 29605
        • Werving
        • Prisma Health Cancer Institute - Faris
        • Hoofdonderzoeker:
          • Suzanne R. Fanning
        • Contact:
      • Greenville, South Carolina, Verenigde Staten, 29605
        • Werving
        • Prisma Health Cancer Institute - Butternut
        • Hoofdonderzoeker:
          • Suzanne R. Fanning
        • Contact:
      • Greenville, South Carolina, Verenigde Staten, 29615
        • Werving
        • Prisma Health Cancer Institute - Eastside
        • Hoofdonderzoeker:
          • Suzanne R. Fanning
        • Contact:
      • Greer, South Carolina, Verenigde Staten, 29650
        • Werving
        • Prisma Health Cancer Institute - Greer
        • Hoofdonderzoeker:
          • Suzanne R. Fanning
        • Contact:
      • Seneca, South Carolina, Verenigde Staten, 29672
        • Werving
        • Prisma Health Cancer Institute - Seneca
        • Hoofdonderzoeker:
          • Suzanne R. Fanning
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, Verenigde Staten, 57104
      • Sioux Falls, South Dakota, Verenigde Staten, 57117-5134
    • Utah
      • Salt Lake City, Utah, Verenigde Staten, 84112
        • Werving
        • Huntsman Cancer Institute/University of Utah
        • Contact:
        • Hoofdonderzoeker:
          • Harsh Shah
    • Vermont
      • Saint Johnsbury, Vermont, Verenigde Staten, 05819
        • Werving
        • Dartmouth Cancer Center - North
        • Contact:
        • Hoofdonderzoeker:
          • Charles Gaulin
    • Virginia
      • Richmond, Virginia, Verenigde Staten, 23235
        • Werving
        • VCU Massey Cancer Center at Stony Point
        • Contact:
        • Hoofdonderzoeker:
          • Bruce O. Hough
      • Richmond, Virginia, Verenigde Staten, 23298
        • Werving
        • VCU Massey Comprehensive Cancer Center
        • Hoofdonderzoeker:
          • Bruce O. Hough
        • Contact:
    • Washington
      • Edmonds, Washington, Verenigde Staten, 98026
        • Werving
        • Swedish Cancer Institute-Edmonds
        • Hoofdonderzoeker:
          • Alison K. Conlin
        • Contact:
      • Issaquah, Washington, Verenigde Staten, 98029
        • Werving
        • Swedish Cancer Institute-Issaquah
        • Hoofdonderzoeker:
          • Alison K. Conlin
        • Contact:
      • Seattle, Washington, Verenigde Staten, 98122
        • Werving
        • Swedish Medical Center-First Hill
        • Hoofdonderzoeker:
          • Alison K. Conlin
        • Contact:
    • Wisconsin
      • Appleton, Wisconsin, Verenigde Staten, 54911
        • Werving
        • ThedaCare Regional Cancer Center
        • Contact:
        • Hoofdonderzoeker:
          • Yazhini Vallatharasu
      • Appleton, Wisconsin, Verenigde Staten, 54911
        • Werving
        • ThedaCare Regional Medical Center - Appleton
        • Contact:
        • Hoofdonderzoeker:
          • Yazhini Vallatharasu
      • Ashland, Wisconsin, Verenigde Staten, 54806
        • Werving
        • Duluth Clinic Ashland
        • Contact:
        • Hoofdonderzoeker:
          • Bret E. Friday
      • Eau Claire, Wisconsin, Verenigde Staten, 54701
      • Johnson Creek, Wisconsin, Verenigde Staten, 53038
        • Werving
        • University of Wisconsin Carbone Cancer Center - Johnson Creek
        • Hoofdonderzoeker:
          • Priyanka Pophali
        • Contact:
      • La Crosse, Wisconsin, Verenigde Staten, 54601
        • Werving
        • Gundersen Lutheran Medical Center
        • Contact:
        • Hoofdonderzoeker:
          • Michael O. Ojelabi
      • Madison, Wisconsin, Verenigde Staten, 53792
        • Werving
        • University of Wisconsin Carbone Cancer Center - University Hospital
        • Hoofdonderzoeker:
          • Priyanka Pophali
        • Contact:
      • Madison, Wisconsin, Verenigde Staten, 53718
        • Werving
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
        • Hoofdonderzoeker:
          • Priyanka Pophali
        • Contact:
      • Marshfield, Wisconsin, Verenigde Staten, 54449
      • Milwaukee, Wisconsin, Verenigde Staten, 53226
        • Werving
        • Medical College of Wisconsin
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 414-805-3666
        • Hoofdonderzoeker:
          • Mehdi Hamadani
      • Minocqua, Wisconsin, Verenigde Staten, 54548
      • Mukwonago, Wisconsin, Verenigde Staten, 53149
        • Werving
        • ProHealth D N Greenwald Center
        • Contact:
        • Hoofdonderzoeker:
          • Timothy R. Wassenaar
      • New Berlin, Wisconsin, Verenigde Staten, 53151
        • Werving
        • Froedtert and MCW Moorland Reserve Health Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 414-805-0505
        • Hoofdonderzoeker:
          • Mehdi Hamadani
      • Oconomowoc, Wisconsin, Verenigde Staten, 53066
        • Werving
        • ProHealth Oconomowoc Memorial Hospital
        • Hoofdonderzoeker:
          • Timothy R. Wassenaar
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 262-928-7878
      • Rice Lake, Wisconsin, Verenigde Staten, 54868
      • Stevens Point, Wisconsin, Verenigde Staten, 54482
      • Waukesha, Wisconsin, Verenigde Staten, 53188
        • Werving
        • UW Cancer Center at ProHealth Care
        • Hoofdonderzoeker:
          • Timothy R. Wassenaar
        • Contact:
      • Weston, Wisconsin, Verenigde Staten, 54476

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

60 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Procedure: Biospecimen Collection

Undergo blood sample collection

Biologisch: Rituximab

Given IV

Procedure: Computed Tomography

Undergo CT

Andere namen:
  • CT-scan
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andere namen:
  • MRI
Ander: Questionnaire Administration

Ancillary studies

Procedure: Positron Emission Tomography

Undergo PET

Andere namen:
  • HUISDIER
Procedure: Colonoscopy

Undergo colonoscopy

Ander: Patient Observation

Undergo observation

Procedure: Esophagogastroduodenoscopy

Undergo EGD

Andere namen:
  • EGD
Geneesmiddel: Zanubrutinib

Given PO

Procedure: Bone Marrow Biopsy

undergo bone marrow biopsy

Ander: Fludeoxyglucose F-18

Given IV
Experimenteel: 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.
Procedure: Biospecimen Collection

Undergo blood sample collection

Procedure: Computed Tomography

Undergo CT

Andere namen:
  • CT-scan
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andere namen:
  • MRI
Ander: Questionnaire Administration

Ancillary studies

Procedure: Positron Emission Tomography

Undergo PET

Andere namen:
  • HUISDIER
Procedure: Colonoscopy

Undergo colonoscopy

Ander: Patient Observation

Undergo observation

Procedure: Esophagogastroduodenoscopy

Undergo EGD

Andere namen:
  • EGD
Geneesmiddel: Zanubrutinib

Given PO

Procedure: Bone Marrow Biopsy

undergo bone marrow biopsy

Ander: Fludeoxyglucose F-18

Given IV
Actieve vergelijker: 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.
Procedure: Biospecimen Collection

Undergo blood sample collection

Procedure: Computed Tomography

Undergo CT

Andere namen:
  • CT-scan
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andere namen:
  • MRI
Ander: Questionnaire Administration

Ancillary studies

Procedure: Positron Emission Tomography

Undergo PET

Andere namen:
  • HUISDIER
Procedure: Colonoscopy

Undergo colonoscopy

Ander: Patient Observation

Undergo observation

Procedure: Esophagogastroduodenoscopy

Undergo EGD

Andere namen:
  • EGD
Geneesmiddel: Zanubrutinib

Given PO

Procedure: Bone Marrow Biopsy

undergo bone marrow biopsy

Ander: Fludeoxyglucose F-18

Given IV

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-free survival (PFS) 1 (Arm A)
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall survival (OS) (Arms A and B)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Alliance for Clinical Trials in Oncology

Medewerkers

National Cancer Institute (NCI)

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 oktober 2023

Primaire voltooiing (Geschat)

31 augustus 2038

Studie voltooiing (Geschat)

31 augustus 2038

Studieregistratiedata

Eerst ingediend

26 juli 2023

Eerst ingediend dat voldeed aan de QC-criteria

26 juli 2023

Eerst geplaatst (Werkelijk)

4 augustus 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • A052101
  • NCI-2023-03577 (Andere identificatie: NCI Clinical Trial Reporting Program)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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