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Bruton Tyrosine Kinase Inhibitor

BTKi + Venetoclax for Chronic Lymphocytic Leukemia (Benefit VA Trial)

Phase 2

Waitlist Available

Led By Suman Kambhampati, MD MBBS

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Patients with CLL or SLL diagnosis

Patients currently receiving CLL/SLL directed therapy with a BTKi for at least six months

Must not have

Patients with history of Richter's transformation or prolymphocytic leukemia

Patients with evidence of chronic hepatitis B virus infection and detectable viral load

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24-36 months

Awards & highlights

Summary

"This trial compares taking BTKi alone for CLL/SLL with adding venetoclax to the treatment for one year. Both pills will then be stopped and participants will be closely monitored."

Who is the study for?

This trial is for veterans with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who are already responding to treatment with a BTK inhibitor. Specific eligibility criteria were not provided, but typically participants must meet certain health standards and may be required to have specific characteristics related to their condition.

What is being tested?

The study is testing whether adding venetoclax, another type of medication for CLL/SLL, to the current treatment with a BTK inhibitor (ibrutinib, acalabrutinib, or zanubrutinib) improves outcomes. Participants will either continue their current BTKi alone or receive it in combination with venetoclax for one year.

What are the potential side effects?

Possible side effects include diarrhea, bleeding problems, high blood pressure from BTK inhibitors; and tumor lysis syndrome (a rapid release of cells into the blood), low white blood cell counts leading to infection risk from venetoclax.

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 or SLL.

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I have been on a BTK inhibitor for my CLL/SLL for at least 6 months.

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My blood tests or scans show signs of CLL/SLL.

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I am 18 years old or older.

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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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I can take pills and don't have serious stomach or bowel problems.

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I can take medication for high uric acid levels.

Exclusion Criteria

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

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I have had Richter's transformation or prolymphocytic leukemia.

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I have chronic hepatitis B with a detectable viral load.

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I have hepatitis C with a detectable viral load.

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I do not have severe heart failure, unstable chest pain, or uncontrolled heart rhythm problems.

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I am not on any strong medication that affects liver enzymes.

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I am currently on blood thinners like heparin or warfarin.

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I have an infection that needs IV antibiotics.

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I have been treated with BTK inhibitors and venetoclax.

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My CLL/SLL cancer progressed despite BTK inhibitor treatment.

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I take more than 20 mg of prednisone or a similar steroid daily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24-36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24-36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-36 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The primary objective is to evaluate complete response (CR) rate, per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria, 2018

Secondary study objectives

CLL/SLL patients' experience through patient reported outcome (PRO) QoL

CLL/SLL patients' experience through patient reported outcome (PRO) measures of fatigue (a key secondary objective)

Measure financial toxicity (FT) in CLL/SLL patients

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B : BTKi + Venetoclax for 12 cycles, then discontinueExperimental Treatment2 Interventions

BTKi + Venetoclax for 12 cycles, then discontinue Experimental Intervention

Group II: Arm A : Continue BTKi single agentActive Control1 Intervention

Continue BTKi single agent (monotherapy) Standard Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~2200

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,647 Previous Clinical Trials

3,359,970 Total Patients Enrolled

Suman Kambhampati, MD MBBSPrincipal InvestigatorKansas City VA Medical Center, Kansas City, MO

~67 spots leftby Jun 2029

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