A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
BeOne Medicines
Study ID
NCT06742996
Phase
PHASE3
Status
Recruiting
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Conditions

  • B Cell Lymphoma
  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sonrotoclax — DRUG
    Administered orally
  • Zanubrutinib — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally

Study Details

The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.

Key Dates

Start date
Mar 5, 2025
Status verified
Jun 2026
Primary completion
Aug 31, 2028
Completion
Mar 30, 2032

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: sonrotoclax plus zanubrutinib
    Sonrotoclax and zanubrutinib will be administered in combination.
  • Placebo Comparator: Arm B: placebo plus zanubrutinib
    Placebo and zanubrutinib will be administered in combination.

Primary Outcome Measure

Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) [ Time Frame: Approximately 41 months ]

Central Contacts

Locations (37)

FacilityCityStateZIPSite coordinators
University of Alabama At Birmingham HospitalBirminghamAlabama35294-0004-
University of Arizona Cancer CenterTucsonArizona85724-0001-
Ucsf FresnoFresnoCalifornia93701-
Kaiser Permanente Southern CaliforniaIrvineCalifornia92618-3734-
Yale University Yale Cancer CenterNew HavenConnecticut06520-8028-
Memorial Cancer Institute, Memorial Healthcare SystemPembroke PinesFlorida33026-4119-
Cleveland Clinic FloridaWestonFlorida33331-3609-
Rush University Medical CenterChicagoIllinois60612-
Fort Wayne Medical Oncology and HematologyFort WayneIndiana46804-
Mission Cancer and BloodWaukeeIowa50263-
University of Maryland Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201-1544-
Dana Farber Cancer Institute Longwood Medical CenterBostonMassachusetts02215-5418-
University of MichiganAnn ArborMichigan48109-1382-
The Cancer and Hematology CentersGrand RapidsMichigan49503-2563-
Mayo Clinic RochesterRochesterMinnesota55905-0001-
Hattiesburg Hematology and Oncology ClinicHattiesburgMississippi39401-7233-
Washington University School of MedicineSt LouisMissouri63110-1010-
Nebraska Cancer Specialists St Francis Grand IslandGrand IslandNebraska68803-
Nebraska Cancer SpecialistsOmahaNebraska68130-2042-
The Valley Hospital, IncParamusNew Jersey07652-
Atrium Health Levine Cancer Institute (Lci)CharlotteNorth Carolina28204-2990-
Duke UniversityDurhamNorth Carolina27710-
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157-
Cleveland Clinic FoundationClevelandOhio44195-0001-
University HospitalsClevelandOhio44106-1716-
Ohio Health Research InstituteColumbusOhio43214-3907-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-1280-
Penn State Milton S Hershey Medical CenterHersheyPennsylvania17033-
McGlinn Cancer InstituteWest ReadingPennsylvania19611-2143-
Tennessee OncologyNashvilleTennessee37205-
Tennessee Oncology Nashville St Thomas Midtown ClinicNashvilleTennessee37205-
Md Anderson Cancer CenterHoustonTexas77030-3907-
Texas Oncology Austin MidtownRound RockTexas78681-4019-
University of VirginiaCharlottesvilleVirginia22908-0817-
Virgina Cancer SpecialistsGainesvilleVirginia20155-3257-
Vcu Massey Cancer CenterRichmondVirginia23298-5026-
Northwest Cancer Specialist, Pc(Us Oncology Research)VancouverWashington98684-6930-

Find similar trials in Birmingham, AL

By research site
University of Alabama At Birmingham Hospital· Birmingham, ALUniversity of Arizona Cancer Center· Tucson, AZUcsf Fresno· Fresno, CAKaiser Permanente Southern California· Irvine, CAYale University Yale Cancer Center· New Haven, CTMemorial Cancer Institute, Memorial Healthcare System· Pembroke Pines, FL

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