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Tyrosine Kinase Inhibitor

Venetoclax + Ibrutinib for Chronic Lymphocytic Leukemia

Phase 2

Waitlist Available

Led By Nitin Jain

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients with a diagnosis of CLL/SLL

Cohort 1: Refractory to and/or relapsed after at least one prior therapy will be eligible

Must not have

Known positive serology for human immunodeficiency virus (HIV), due to potential drug-drug interactions between anti-retroviral medications and the study drugs

Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 2 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how well two drugs work to treat patients with chronic or small lymphocytic leukemia. Venetoclax may stop cancer cell growth by blocking a protein needed for cell survival. Ibrutinib may stop cancer cell growth by blocking enzymes needed for cell growth.

Who is the study for?

This trial is for patients with chronic or small lymphocytic leukemia who are in good physical condition (ECOG <=2) and have properly functioning kidneys and liver. It includes those untreated with high-risk features, relapsed after prior therapy, or free from other malignancies for 2 years. Pregnant women, HIV-positive individuals, those with active infections or hepatitis B/C, recent recipients of certain therapies, and anyone on strong CYP3A inhibitors/inducers can't participate.

What is being tested?

The study tests the combination of venetoclax and ibrutinib to treat chronic/small lymphocytic leukemia. Venetoclax aims to block a protein that cancer cells need to survive while Ibrutinib targets enzymes important for cell growth. The goal is to see if this drug combo can control the disease better than current treatments.

What are the potential side effects?

Potential side effects include digestive issues like nausea or diarrhea; low blood counts leading to increased infection risk; fatigue; possible liver function changes; allergic reactions; bleeding problems due to low platelets; muscle and bone pain.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with CLL/SLL.

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My condition did not improve after at least one treatment.

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I can take care of myself and am up and about more than half of the day.

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My kidneys work well enough to clear at least 50 mL/min of creatinine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am HIV positive and understand there may be interactions with my medication.

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I do not have serious heart problems like uncontrolled heart rhythm issues or recent heart attacks.

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I have been treated with venetoclax or ibrutinib before.

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I cannot take medications by mouth due to a digestive condition.

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I have an active autoimmune condition needing high-dose steroids.

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I have not taken strong CYP3A inhibitors or inducers in the last 7 days.

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I haven't had major treatments or experimental drugs for my condition in the last 3 weeks.

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I do not have an untreated ongoing infection.

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I have active hepatitis C confirmed by a specific blood test.

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I am currently taking warfarin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Best response (complete response /complete response with incomplete recovery) of combined ibrutinib and venetoclax

Secondary study objectives

Complete response/complete response with incomplete recovery rate in each subgroups of patients

Incidence of toxicities

Overall survival

+2 more

Other study objectives

Changes in immunological biomarkers

Body Weight Changes

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: Treatment (ibrutinib, venetoclax)Experimental Treatment3 Interventions

Patients receive ibrutinib PO QD on days 1-28. Beginning on day 1 of cycle 4, patients also receive venetoclax PO QD on days 1-28. Treatment repeats every 28 days for up to 27 cycles in the absence of disease progression or unacceptable toxicity. Patients with residual disease or who are positive for MRD after cycle 27 may continue treatment with ibrutinib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibrutinib

2014

Completed Phase 4

~2060

Venetoclax

2019

Completed Phase 3

~2240