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Testing av kontinuerlig versus intermitterende behandling med studiemedisinen Zanubrutinib for eldre pasienter med tidligere ubehandlet mantelcellelymfom

2. november 2026 oppdatert av: Alliance for Clinical Trials in Oncology

En randomisert fase 3-studie av kontinuerlig vs. intermitterende vedlikeholdsterapi med Zanubrutinib som forhåndsbehandling hos eldre pasienter med mantelcellelymfom

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

421

Fase

  • Fase 3

Kontakter og plasseringer

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

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

Deltakelseskriterier

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

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

60 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Fremgangsmåte: Biospecimen Collection

Undergo blood sample collection

Biologisk: Rituximab

Given IV

Fremgangsmåte: Computed Tomography

Undergo CT

Andre navn:
  • CAT-skanning
  • CT skann
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
Annen: Questionnaire Administration

Ancillary studies

Fremgangsmåte: Positron Emission Tomography

Undergo PET

Andre navn:
  • KJÆLEDYR
Fremgangsmåte: Colonoscopy

Undergo colonoscopy

Annen: Patient Observation

Undergo observation

Fremgangsmåte: Esophagogastroduodenoscopy

Undergo EGD

Andre navn:
  • EGD
Legemiddel: Zanubrutinib

Given PO

Fremgangsmåte: Bone Marrow Biopsy

undergo bone marrow biopsy

Annen: Fludeoxyglucose F-18

Given IV
Eksperimentell: 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.
Fremgangsmåte: Biospecimen Collection

Undergo blood sample collection

Fremgangsmåte: Computed Tomography

Undergo CT

Andre navn:
  • CAT-skanning
  • CT skann
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
Annen: Questionnaire Administration

Ancillary studies

Fremgangsmåte: Positron Emission Tomography

Undergo PET

Andre navn:
  • KJÆLEDYR
Fremgangsmåte: Colonoscopy

Undergo colonoscopy

Annen: Patient Observation

Undergo observation

Fremgangsmåte: Esophagogastroduodenoscopy

Undergo EGD

Andre navn:
  • EGD
Legemiddel: Zanubrutinib

Given PO

Fremgangsmåte: Bone Marrow Biopsy

undergo bone marrow biopsy

Annen: Fludeoxyglucose F-18

Given IV
Aktiv komparator: 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.
Fremgangsmåte: Biospecimen Collection

Undergo blood sample collection

Fremgangsmåte: Computed Tomography

Undergo CT

Andre navn:
  • CAT-skanning
  • CT skann
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
Annen: Questionnaire Administration

Ancillary studies

Fremgangsmåte: Positron Emission Tomography

Undergo PET

Andre navn:
  • KJÆLEDYR
Fremgangsmåte: Colonoscopy

Undergo colonoscopy

Annen: Patient Observation

Undergo observation

Fremgangsmåte: Esophagogastroduodenoscopy

Undergo EGD

Andre navn:
  • EGD
Legemiddel: Zanubrutinib

Given PO

Fremgangsmåte: Bone Marrow Biopsy

undergo bone marrow biopsy

Annen: Fludeoxyglucose F-18

Given IV

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-free survival (PFS) 1 (Arm A)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall survival (OS) (Arms A and B)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

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

Sponsor

Alliance for Clinical Trials in Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Studierekorddatoer

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

Studer hoveddatoer

Studiestart (Faktiske)

20. oktober 2023

Primær fullføring (Antatt)

31. august 2038

Studiet fullført (Antatt)

31. august 2038

Datoer for studieregistrering

Først innsendt

26. juli 2023

Først innsendt som oppfylte QC-kriteriene

26. juli 2023

Først lagt ut (Faktiske)

4. august 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A052101
  • NCI-2023-03577 (Annen identifikator: NCI Clinical Trial Reporting Program)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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

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