A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
BeiGene
Study ID
NCT03734016
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Zanubrutinib — DRUG
    160 mg orally twice daily
  • Ibrutinib — DRUG
    Ibrutinib 420 mg orally once daily

Study Details

This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Key Dates

Start date
Nov 1, 2018
Status verified
Mar 2025
Primary completion
Aug 8, 2022
Completion
Feb 28, 2024

Study Design

Enrollment
652 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Zanubrutinib
    Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
  • Active Comparator: Ibrutinib
    Participants received Ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

Primary Outcome Measure

Overall Response Rate (ORR) Assessed by the Investigator [ Time Frame: From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). ]

Locations (30)

FacilityCityStateZIPSite coordinators
Carti Cancer CenterLittle RockArkansas72205-
David Geffen School of Medicine At UCLALos AngelesCalifornia90095-
Rocky Mountain Cancer Centers BoulderBoulderColorado80303-
Scri Florida Cancer Specialists SouthFort MyersFlorida33901-
Scri Florida Cancer Specialists NorthSt. PetersburgFlorida33705-
Augusta UniversityAugustaGeorgia30912-
Norton Cancer Institute PavilionLouisvilleKentucky40207-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Forrest General Hospital Cancer CenterHattiesburgMississippi39401-
Scri Hca Midwest HealthKansas CityMissouri64132-
Nebraska Medical CenterOmahaNebraska68198-
Comprehensive Cancer Centers of NevadaLas VegasNevada89169-
Atlantic Health SystemMorristownNew Jersey07960-
Morristown Medical CenterMorristownNew Jersey07960-
Columbia University Medical CenterNew YorkNew York10032-
Clinical Research Alliance, IncWestburyNew York11590-
Duke University HospitalDurhamNorth Carolina27705-
Oregon Health and Science UniversityPortlandOregon97239-
Willamette Valley Cancer CenterSpringfieldOregon97477-
Scri Tennessee Oncology ChattanoogaChattanoogaTennessee37404-
Sarah Cannon Cancer CenterNashvilleTennessee37203-
Texas Oncology Fort Worth Cancer CenterFort WorthTexas76104-2150-
The University of Texas Md Anderson Cancer CenterHoustonTexas77030-4009-
Joe Arrington Cancer Research and Treatment CenterLubbockTexas79410-
Texas Oncology San Antonio Medical Center UsorSan AntonioTexas78240-
Texas Oncology Tyler LongviewTylerTexas75702-
Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)RoanokeVirginia24014-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-
Va Puget Sound Health Care SystemSeattleWashington98108-
Medical Oncology AssociatesSpokaneWashington99208-

Find similar trials in Little Rock, AR

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Carti Cancer Center· Little Rock, ARDavid Geffen School of Medicine At UCLA· Los Angeles, CARocky Mountain Cancer Centers Boulder· Boulder, COScri Florida Cancer Specialists South· Fort Myers, FLScri Florida Cancer Specialists North· St. Petersburg, FLAugusta University· Augusta, GA

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