Zanubrutinib, Obinutuzumab, and Sonrotoclax in Previously Untreated Patients With CLL or SLL

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06849713
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Zanubrutinib — DRUG
    Bruton's Tyrosine Kinase (BTK) inhibitor
  • Sonrotoclax — DRUG
    B-cell lymphoma 2 (BCL2) protein inhibitor
  • Obinutuzumab — DRUG
    Anti-CD20 monoclonal antibody

Study Details

The purpose of this study is to determine the proportion of participants who achieve undetectable measurable residual disease (uMRD) in previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Key Dates

Start date
May 16, 2025
Status verified
May 2026
Primary completion
Mar 1, 2028
Completion
Mar 1, 2030

Study Design

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

Arms

  • Experimental: Zanubrutinib, obinutuzumab, and sonrotoclax
    Zanubrutinib will be taken orally twice daily on days 1-28 of each cycle. Sonrotoclax will be taken orally once daily on days 1-28 starting cycle 3 day 1. Obinutuzumab will be given into the vein (by intravenous infusion) at the following timepoints: Days 1, 8, and 15 of cycle 1, Day 2 of cycle 1, and Day 1 of cycles 2 through 6. The total regimen treatment duration depends on early MRD response kinetics (ΔMRD400). The total regimen treatment duration will be 10 cycles for patients who achieve ΔMRD400 and 24 cycles for patients who do not achieve ΔMRD400 (including the 2-month zanubrutinib/obinutuzumab lead-in). Drug diaries will be provided to participants to document information about zanubrutinib and sonrotoclax.

Primary Outcome Measure

Rate of Undetectable MRD (uMRD) at Best Response [ Time Frame: Day 1 to 2 years after final patient enrolled ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Jacob Soumerai, MD
[email protected]
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Andew D Zelenetz, MD, PhD
[email protected]
212-639-2656

Find similar trials in Boston, MA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Massachusetts General Hospital· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NY

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