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Monoclonal Antibodies

Triple Combo Therapy for Chronic Lymphocytic Leukemia

Phase 2

Recruiting

Led By Andrew Zelenetz, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Age ≥18 years

Diagnosis of the following histories according to the WHO criteria: CLL or SLL, MCL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combo treatment for CLL/SLL to see how effective it is at getting rid of disease.

Who is the study for?

Adults diagnosed with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), who haven't had systemic therapy for these conditions, can join. They should be in a stable health condition and willing to use effective contraception. People with other active cancers, serious infections, or certain heart/liver diseases cannot participate.

What is being tested?

The trial is testing the combination of three drugs: Zanubrutinib, Obinutuzumab, and Venetoclax in patients with CLL/SLL. The goal is to see if this drug combo can eliminate all detectable traces of the disease from the body.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as infusion reactions, bleeding issues due to blood disorders, liver problems, infections due to weakened immunity and may affect fertility.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with CLL, SLL, or MCL according to WHO standards.

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I can take care of myself and am up and about more than half of my waking hours.

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I agree not to donate sperm or eggs during and up to 18 months after treatment.

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My blood test shows at least 1% of my white blood cells are CLL-like.

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My kidney and liver tests are within normal ranges.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

establish the rate of minimum residual disease (MRD) undetectable response

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: BOVEN regimenExperimental Treatment3 Interventions

Patients will be given zanubrutinib (160mg by mouth BID) and 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). 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zanubrutinib

2017

Completed Phase 3

~2160

Obinutuzumab

2014

Completed Phase 3

~3470