A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors

Part of paid clinical trials in Jonesboro, Arkansas.

Sponsor
BeOne Medicines
Study ID
NCT06846671
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • BGB-16673 — DRUG
    Administered orally
  • Bendamustine — DRUG
    Administered intravenously
  • Idelalisib — DRUG
    Administered orally
  • Rituximab — DRUG
    Administered intravenously
  • Venetoclax — DRUG
    Administered orally

Study Details

The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (idelalisib plus rituximab \[for CLL only\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).

Key Dates

Start date
Apr 10, 2025
Status verified
May 2026
Primary completion
May 15, 2028
Completion
Feb 14, 2030

Study Design

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

Arms

  • Experimental: Arm A: BGB-16673 monotherapy
    Participants will receive BGB-16673 once daily until any of the treatment discontinuation criteria are met
  • Active Comparator: Arm B: Investigator's Choice
    Participants will receive investigator's choice of idelalisib plus rituximab for CLL only or bendamustine plus rituximab, or venetoclax plus rituximab retreatment.

Primary Outcome Measure

Progression-Free Survival (PFS) by Independent Review Committee (IRC) [ Time Frame: Approximately 36 Months ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
St Bernards Medical CenterJonesboroArkansas72401-
UCLA Department of Medicine HematologyoncologyLos AngelesCalifornia90095-3075-
Pih Health Whittier HospitalWhittierCalifornia90602-
Rocky Mountain Cancer Centers (Williams) UsorAuroraColorado80012-5405-
Florida Oncology and HematologyFort MyersFlorida33912-
Baptist Md Anderson Cancer CenterJacksonvilleFlorida32207-8432-
Cleveland Clinic FloridaWestonFlorida33331-3609-
Emory University Winship Cancer InstituteAtlantaGeorgia30322-1013-
Northside Cancer CenterAtlantaGeorgia30342-
Our Lady of the Lake HospitalBaton RougeLouisiana70808-4365-
American Oncology Partners of Maryland PaBethesdaMaryland20817-7847-
Oncology Hematology AssociatesSpringfieldMissouri65807-5288-
Oncology Hematology West, Pc Dba Nebraska Cancer SpecialistsOmahaNebraska68130-2042-
Memorial Sloan Kettering Cancer Center MskccNew YorkNew York10065-6800-
Clinical Research Alliance, IncWestburyNew York11590-5119-
University HospitalsClevelandOhio44106-1716-
Dayton Physician NetworkDaytonOhio45415-
Oncology Associates of Oregon Willamette Valley Cancer CenterEugeneOregon97401-
West Penn HospitalPittsburghPennsylvania15224-
Cancer Care Associates of YorkYorkPennsylvania17403-5049-
Texas Oncology TylerTylerTexas75702-7522-

Find similar trials in Jonesboro, AR

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
St Bernards Medical Center· Jonesboro, ARUCLA Department of Medicine Hematologyoncology· Los Angeles, CAPih Health Whittier Hospital· Whittier, CARocky Mountain Cancer Centers (Williams) Usor· Aurora, COFlorida Oncology and Hematology· Fort Myers, FLBaptist Md Anderson Cancer Center· Jacksonville, FL

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