A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07674810
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Zanubrutinib — DRUG
    Given orally
  • Obinutuzumab — DRUG
    Given orally
  • Sonrotoclax — DRUG
    Given orally

Study Details

The goal of this clinical research study is to learn if the combination of zanubrutinib, sonrotoclax, and obinutuzumab can help to control previously untreated CLL/SLL.

Key Dates

Start date
Dec 31, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2029

Study Design

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

Arms

  • Experimental: Treatment with Zanubrutinib (PO) + Sonrotoclax (PO) + Obinutuzumab (IV) Q4W
    Each cycle will be 4 weeks in length. Participants will receive zanubrutinib orally 320 mg once daily continuously starting Cycle 1 Day 1 (C1D1) and will continue as monotherapy through cycle 3. Starting in cycle 4, participants will receive sonrotoclax orally starting C4D1 with a weekly dose escalations schedule to a target dose of 320 mg daily in combination with zanubrutinib. Participants will continue combination therapy with zanubrutinib and sonrotoclax from Cycle4 through Cycle 15 (12 cycles total). Obinutuzumab will be added starting in cycle 10 and given for 6 cycles (Cycles 10-15).

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)

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
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By research site
UT MD Anderson· Houston, TX

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