A Randomized Phase II Study Of Bruton Tyrosine Kinase Inhibitor With Or Without Venetoclax In Veterans With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Part of paid clinical trials in San Francisco, California.

Sponsor
VA Office of Research and Development
Study ID
NCT06520098
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    VENCLEXTA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy.
  • Ibrutinib, Acalabrutinib, Zanubrutinib — DRUG
    IMBRUVICA is a kinase inhibitor Acalabrutinib is a selective, irreversible small molecule inhibitor of BTK. Zanubrutinib is BTK inhibitors

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Oct 2025
Primary completion
Jun 30, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A : Continue BTKi single agent
    Continue BTKi single agent (monotherapy) Standard Intervention
  • Experimental: Arm B : BTKi + Venetoclax for 12 cycles, then discontinue
    BTKi + Venetoclax for 12 cycles, then discontinue Experimental Intervention

Primary Outcome Measure

The primary objective is to evaluate complete response (CR) rate, per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria, 2018 [ Time Frame: 24-36 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
San Francisco VA Medical Center, San Francisco, CASan FranciscoCalifornia94121-1563
Gerald Hsu, MD
[email protected]
415-221-4810
Kansas City VA Medical Center, Kansas City, MOKansas CityMissouri64128-2226
Murali K Nittala, MBBS MS MD
[email protected]
816-861-4700
Suman Kambhampati, MD MBBS (PRINCIPAL_INVESTIGATOR)
Durham VA Medical Center, Durham, NCDurhamNorth Carolina27705-3875
Daphne Friedman, MD
[email protected]
919-286-0411
VA Puget Sound Health Care System Seattle Division, Seattle, WASeattleWashington98108-1532
Jeannine Barton
[email protected]
206-277-3101

Find similar trials in San Francisco, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
San Francisco VA Medical Center, San Francisco, CA· San Francisco, CAKansas City VA Medical Center, Kansas City, MO· Kansas City, MODurham VA Medical Center, Durham, NC· Durham, NCVA Puget Sound Health Care System Seattle Division, Seattle, WA· Seattle, WA

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