A Phase 2 Trial Of The Bruton Tyrosine Kinase Degrader BGB-16673 In Combination With BCL-2 Inhibitor Sonrotoclax For Patients With Treatment-Naive Chronic Lymphocytic Leukemia (CLL)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07508995
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Chronic Lymphocytic Leukemia (CLL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • BGB-16673 — DRUG
    Given by mouth
  • BGB-11417 — DRUG
    Given by mouth

Study Details

This is an open-label, single-arm, phase II study which will assess the safety and efficacy of BGB16673 in combination with sonrotoclax as a time-limited approach for participants with treatment-naive CLL/SLL.

Key Dates

Start date
Sep 1, 2026
Status verified
Mar 2026
Primary completion
Jul 1, 2031
Completion
Jul 1, 2033

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 2: Treatment with BGB-16673 + Sonrotoclax
    Treatment will be administered on an outpatient basis. However, hospitalization is recommended at each ramp-up dose increase until 24 hours after the dose for participants with high tumor burden at TLS Risk Reassessment.

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD AndersonHoustonTexas77030
Nitin Jain, MBBS
[email protected]
713-745-6080
Nitin Jain, MBBS (PRINCIPAL_INVESTIGATOR)

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By research site
UT MD Anderson· Houston, TX

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