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Bruton Tyrosine Kinase Inhibitor

Arm B : BTKi + Venetoclax for 12 cycles, then discontinue 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
* CLL or SLL diagnosis
* Patients must have been diagnosed with CLL (\> 5000 B-cells per uL of peripheral blood at any point during the course of their disease) or small lymphocytic lymphoma (SLL) with \<5000 B-cells per µL of blood but with disease-associated lymphadenopathy by 2018 IWCLL criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-36 months
Awards & highlights

Summary

People who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) are often treated with ibrutinib, acalabrutinib, or zanubrutinib. These are pills that are taken by mouth. This type of pill is called "Bruton Tyrosine Kinase Inhibitor" or BTKi. Another treatment for CLL/SLL is a different pill called venetoclax. The purpose of this study is to compare continuing the current treatment with BTKi alone, as long as it is working, to another arm of treatment which adds venetoclax to the current treatment (BTKi), for one year. After one year, both pills in this arm of treatment would be stopped and the 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

Timeline

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
~1990

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,642 Previous Clinical Trials
3,352,491 Total Patients Enrolled
Suman Kambhampati, MD MBBSPrincipal InvestigatorKansas City VA Medical Center, Kansas City, MO
~67 spots leftby Jun 2029
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