RecruitingPhase 2NCT03824483

Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)

Phase 2 Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) and Mantle Cell Lymphoma (MCL)

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

230 participants

Start Date

Feb 22, 2019

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Leukemia (SLL)

Summary

The purpose of this study is to determine the rate of minimum residual disease (MRD) negative response (i.e. the rate of no evidence of disease) of the study drugs, zanubrutinib, obinutuzumab, and venetoclax, given in combination as a treatment for CLL and/or SLL.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of three targeted drugs — zanubrutinib, obinutuzumab, and venetoclax — for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), two closely related types of slow-growing blood cancers, who have not yet received systemic treatment. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with CLL, SLL, or mantle cell lymphoma (MCL) - You have not previously received chemotherapy or other systemic treatment for this condition - Your blood tests confirm the presence of the relevant cancer cells **You may NOT be eligible if...** - You have already received systemic drug treatment for your CLL/SLL/MCL (limited prior radiation or short courses of steroids may be permitted) - Your disease does not meet the required laboratory criteria - Your overall health or organ function prevents you from safely taking these medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZanubrutinib

zanubrutinib (160mg by mouth BID)

DRUGObinutuzumab

obinutuzumab (1000mg IVPB on Days 1\*, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 8) starting on Cycle 1 (28-day cycles). \* On Cycle 1, obinituzumab will be administered in "split dose" at 100mg IVPB on Day 1 and 900mg IVPB on Day 2 in patients at increased risk for IRR (ALC \>25,000 cells/ul or baseline lymph nodes \>5 cm diameter).

DRUGVenetoclax

Venetoclax will be added to the regimen starting on Cycle 3, and will be incorporated into the regimen using the 5-week ramp-up schedule to mitigate the risk of tumor lysis syndrome (beginning at 20mg and gradually increasing to 400mg), and venetoclax will be administered a ta fixed dose level of 400mg by mouth daily of 28-day cycles thereafter.