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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of mutation negative status after 12 courses of combination therapy of ibrutinib and venetoclax
Secondary outcome measures
Therapeutic procedure
Overall survival after beginning venetoclax in combination with ibrutinib
Progression-free survival after adding venetoclax to ibrutinib
+1 more

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
~1890
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
321 Previous Clinical Trials
290,107 Total Patients Enrolled
Kerry Rogers, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
2 Previous Clinical Trials
123 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks could arise from taking Venetoclax?

"The safety of Venetoclax was rated a 2 as this is a Phase 2 clinical trial, indicating there has been some evidence collected on its safety but not yet efficacy."

Answered by AI

Are there additional studies that have been conducted on Venetoclax?

"Presently, 343 studies are in progress focusing on Venetoclax. 45 of these trials have entered the third phase and most of them are located in Edmonton, Alberta. However, there is a total of 11,699 sites conducting research with this drug."

Answered by AI

Are there any slots remaining to participate in this medical investigation?

"This medical research project is no longer recruiting participants, as the latest update to this trial was recorded on April 8th 2022. If you're looking for similar studies, 1522 clinical trials involving ibrutinib are actively enrolling patients and 343 Venetoclax-centred investigations are in need of volunteers."

Answered by AI

What has been the primary application for Venetoclax?

"Venetoclax has been found to be a successful treatment for waldenstrom macroglobulinemia, small lymphocytic lymphoma and chronic lymphocytic leukemia (CLL)."

Answered by AI

What is the current number of participants in this experiment?

"At this time, recruitment for the trial has ceased. Initially posted on March 26th 2019, and last amended April 8th 2022; if you are looking to join an alternative study there are 1522 ibrutinib trials currently recruiting and 343 Venetoclax investigations accepting participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Venetoclax and Ibrutinib in Treating in Participants With Chronic Lymphocytic Leukemia and Ibrutinib Resistance Mutations
Kerry Rogers 2019. "Venetoclax and Ibrutinib in Treating in Participants With Chronic Lymphocytic Leukemia and Ibrutinib Resistance Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03513562.
All > Cll > Chronic Lymphocytic Leukemia
~3 spots leftby Dec 2024
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