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Tyrosine Kinase Inhibitor

Venetoclax + Ibrutinib for Chronic Lymphocytic Leukemia

Phase 2

Waitlist Available

Led By Kerry Rogers, MD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Presence of a known ibrutinib resistance mutation at ≥ 4% variant allele frequency OR < 4% with two separate measurements at least 4 weeks apart with increasing variant allele frequency

Creatinine clearance ≥ 40 mL/min/1.73m^2 using 24-hour creatinine clearance or modified Cockcroft-Gault equation

Must not have

Inability to continue taking ibrutinib for any reason

Uncontrolled autoimmune hemolytic anemia or thrombocytopenia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well venetoclax and ibrutinib work to treat people with CLL who have developed genetic mutations after being treated with ibrutinib. Venetoclax and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Who is the study for?

This trial is for people with chronic lymphocytic leukemia who have developed resistance to a drug called Ibrutinib. Participants must have certain blood cell counts, be able to perform daily activities with minimal assistance (ECOG ≤ 2), and show specific genetic mutations linked to the resistance. They should not have uncontrolled autoimmune reactions affecting their blood cells.

What is being tested?

The study is testing the combination of two drugs, Venetoclax and Ibrutinib, in patients whose leukemia has stopped responding to Ibrutinib alone. The goal is to see if this combo can block cancer growth by shutting down enzymes that cancer cells need.

What are the potential side effects?

Venetoclax and Ibrutinib might cause side effects like diarrhea, nausea, fatigue, risk of infection due to low white blood cell count, bleeding or bruising more easily than normal because of low platelets.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has a mutation resistant to ibrutinib, confirmed by tests.

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My kidneys are functioning well enough for treatment.

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I can swallow pills.

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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 have been diagnosed with chronic lymphocytic leukemia according to WHO or IWCLL standards.

Exclusion Criteria

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

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I cannot continue taking ibrutinib for any reason.

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I have uncontrolled autoimmune blood disorders.

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I feel fine at rest but get tired or short of breath with normal activities.

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I haven't taken strong medication that affects liver enzymes recently.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I cannot swallow pills or have a condition that affects my gut's ability to absorb them.

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I am not pregnant, breastfeeding, nor planning to become pregnant.

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I am HIV positive.

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I am on a blood thinner that is not warfarin.

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My leukemia or lymphoma has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Rate of mutation negative status after 12 courses of combination therapy of ibrutinib and venetoclax

Secondary study objectives

Therapeutic procedure

Overall survival after beginning venetoclax in combination with ibrutinib

Progression-free survival after adding venetoclax to ibrutinib

+1 more

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 (venetoclax, ibrutinib)Experimental Treatment3 Interventions

Participants receive venetoclax PO daily on days 1-28 and ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 12 or 24 courses in the absence of disease progression or unacceptable toxicity. Participants with MRD negativity after 12 or 24 courses discontinue treatment, while participants with MRD positivity continue treatment with venetoclax in the absence of disease progression or unacceptable toxicity.

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