Zanubrutinib + Venetoclax for Chronic B-Cell Leukemia

Phase 2

Recruiting

Led By John Allan, M.D.

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 23 (month 23)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if using two drugs, instead of three, to treat CLL/SLL patients reduces side effects and improves outcomes.

Who is the study for?

This trial is for adults with confirmed chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL) who need treatment but haven't had any cancer therapy before. They must be able to follow pregnancy prevention measures if applicable. Exclusions include recent heart issues, severe infections, certain blood disorders, previous malignancies (except some skin cancers), and known allergies to the study drugs.

What is being tested?

The trial tests a new approach using Zanubrutinib and Venetoclax pills as initial therapy for CLL, adding Obinutuzumab injections only if minimal residual disease is detected after treatment. The goal is to reduce unnecessary medication use while trying to increase the rate of no detectable cancer.

What are the potential side effects?

Possible side effects from these medications may include diarrhea, bleeding problems, infections due to low white blood cell counts, fatigue, nausea or vomiting. Reactions at injection sites are also possible with Obinutuzumab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 23 (month 23)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 23 (month 23)

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 23 (month 23) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of eligible patients that have achieved undetectable minimal residual disease (MRD) at cycle 23, as assessed via bone marrow aspirate

Percentage of eligible patients that have achieved undetectable minimal residual disease (MRD) at cycle 23, as assessed via peripheral blood

Percentage of total patients that have achieved undetectable minimal residual disease (MRD) at cycle 16, as assessed via bone marrow aspirate

+1 more

Secondary study objectives

36-month Overall Survival (OS)

36-month Progression Free Survival (PFS)

36-month Time to Next Treatment (TTNT)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Triple Therapy (Zanubrutinib, Venetoclax, and Obinutuzumab)Experimental Treatment3 Interventions

Participants that meet definition of MRD positivity at C16D1 will enter the triple therapy arm (zanubrutinib, venetoclax, and obinutuzumab). These participants will continue combination therapy with zanubrutinib and venetoclax, but will also receive 6 cycles of obinutuzumab starting at C17D1. In this subgroup, peripheral blood and bone marrow MRD assessments will occur after an additional 6 cycles of the triplet combination therapy (C23D1) at which point all participants will stop study treatment regardless of MRD status.

Group II: Double Therapy (Zanubrutinib plus Venetoclax)Experimental Treatment2 Interventions

All participants will receive an initial 3 cycles of zanubrutinib monotherapy. This lead-in period will then be followed by 12 cycles of zanubrutinib and venetoclax combination therapy. All participants will complete 12 cycles of zanubrutinib and venetoclax combination therapy or 15 cycles of total treatment. Peripheral blood and bone marrow MRD assessments will occur at C16D1. Participants will continue on double combination treatment for an additional 1 month while results of MRD testing are obtained. In total, all participants will be on treatment for at least 16 full cycles. Participants that meet definition of MRD negativity will stop therapy at C17D1 and enter an observation phase with study visits every 3 months. Participants that remain MRD positive at C16D1 will enter the triple therapy (zanubrutinib, venetoclax, and obinutuzumab) arm.

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