A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
BeOne Medicines
Study ID
NCT06973187
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Tacabrutideg — DRUG
    Tacabrutideg will be administered orally
  • Pirtobrutinib — DRUG
    Pirtobrutinib will be administered orally

Study Details

The purpose of this study is to evaluate the efficacy and safety of tacabrutideg alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).

Key Dates

First listed
May 15, 2025
Start date
Sep 4, 2025
Status verified
Aug 2026
Primary completion
Apr 17, 2028
Completion
Apr 17, 2028

Study Design

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

Arms

  • Experimental: Arm A: Tacabrutideg
    Participants will receive tacabrutideg orally.
  • Active Comparator: Arm B: Pirtobrutinib
    Participants will receive pirtobrutinib orally.

Primary Outcome Measure

Progression-Free Survival (PFS) per Independent Review Committee (IRC) [ Time Frame: Up to approximately 3 years ]

Central Contacts

Locations (46)

FacilityCityStateZIPSite coordinators
University of Alabama At Birmingham HospitalBirminghamAlabama35294-0004-
Mayo Clinic PhoenixPhoenixArizona85054-4502-
Kaiser Permanente Southern CaliforniaIrvineCalifornia92618-3734-
University of California San Diego (Ucsd) Moores Cancer CenterLa JollaCalifornia92093-1503-
Cancer and Blood Specialty ClinicLos AlamitosCalifornia90720-3302-
UCLA Department of Medicine HematologyoncologyLos AngelesCalifornia90095-3075-
Kaiser Permanente Oakland Medical CenterOaklandCalifornia94611-
Stanford Cancer InstitutePalo AltoCalifornia94304-2205-
Kaiser Permanente Roseville Medical CenterRosevilleCalifornia95661-
Kaiser Permanente San Francisco Medical Center OncologySan FranciscoCalifornia94115-
Kaiser Permanente Santa Clara Medical Center OncologyhematologySanta ClaraCalifornia95051-
Kaiser Permanente Northern CaliforniaVallejoCalifornia94589-2441-
Kaiser Permanente Walnut Creek Medical CenterWalnut CreekCalifornia94596-
Christiana CareNewarkDelaware19713-2055-
Medstar Georgetown University HospitalWashington D.C.District of Columbia20007-2113-
Cancer Specialists of North FloridaJacksonvilleFlorida32256-
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-1865-
Mount Sinai Medical Center Braman Comprehensive Cancer CenterMiamiFlorida33140-
University of Chicago Medical CenterChicagoIllinois60637-1443-
Mission Cancer and BloodWaukeeIowa50263-
The University of Kansas Cancer CenterWestwoodKansas66205-2003-
Mary Bird Perkins Cancer CenterBaton RougeLouisiana70809-3738-
Our Lady of the Lake HospitalBaton RougeLouisiana70808-4365-
Ochsner Clinic FoundationNew OrleansLouisiana70121-2429-
Dana Farber Cancer InstituteBostonMassachusetts02215-5418-
Karmanos Cancer InstituteDetroitMichigan48201-2013-
Mayo Clinic RochesterRochesterMinnesota55905-0001-
Washington University School of MedicineSt LouisMissouri63110-1010-
Titan Health Partners Llc Dba Astera Cancer CareEast BrunswickNew Jersey08816-4096-
John Theurer Cancer Center Hackensack University Medical CenterHackensackNew Jersey07601-
Columbia University Medical CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer Center MskccNew YorkNew York10065-6800-
University of RochesterRochesterNew York14642-0001-
University of North Carolina At Chapel HillChapel HillNorth Carolina27514-4220-
Atrium Health Levine Cancer Institute (Lci)CharlotteNorth Carolina28204-2990-
Duke University Medical CenterDurhamNorth Carolina27705-3976-
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157-
Dayton Physician NetworkDaytonOhio45415-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-2434-
Tennessee Oncology, Pllc NashvilleNashvilleTennessee37203-
Md Anderson Cancer CenterHoustonTexas77030-3907-
Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)RoanakeVirginia24014-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-4433-
Summit Cancer CentersSpokaneWashington99208-1129-
Northwest Medical SpecialtiesTacomaWashington98405-
Gunderson Health SystemLa CrosseWisconsin54601-5467-

Find similar trials in Birmingham, AL

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By condition
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By specialty
OncologyBlood cancer
By research site
University of Alabama At Birmingham Hospital· Birmingham, ALMayo Clinic Phoenix· Phoenix, AZKaiser Permanente Southern California· Irvine, CAUniversity of California San Diego (Ucsd) Moores Cancer Center· La Jolla, CACancer and Blood Specialty Clinic· Los Alamitos, CAUCLA Department of Medicine Hematologyoncology· Los Angeles, CA

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