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)
NCT Number: NCT06520098
Acronym: Benefit VA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Chronic Lymphocytic Leukemia|Small Lymphocytic Lymphoma
Interventions: DRUG: Venetoclax|DRUG: Ibrutinib, Acalabrutinib, Zanubrutinib
Sponsor: VA Office of Research and Development
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2029-12-31
Locations: San Francisco VA Medical Center, San Francisco, CA, San Francisco, California, 94121-1563, United States|Kansas City VA Medical Center, Kansas City, MO, Kansas City, Missouri, 64128-2226, United States|Durham VA Medical Center, Durham, NC, Durham, North Carolina, 27705-3875, United States|VA Puget Sound Health Care System Seattle Division, Seattle, WA, Seattle, Washington, 98108-1532, United States

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.

Primary Outcome Measures: The primary objective is to evaluate complete response (CR) rate, per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria, 2018, The addition of Venetoclax to BTKi for 12 months will improve CR compared to use of BTKi alone in CLL/SLL patients who are already receiving BTKi therapy as treatment., 24-36 months
Secondary Outcome Measures: CLL/SLL patients' experience through patient reported outcome (PRO) measures of fatigue (a key secondary objective), The addition of Venetoclax to BTKi for 12 months is anticipated to improve cancer-related fatigue as compared to use of BTKi alone in CLL/SLL patients. FACIT-Fatigue PRO instrument will be used., 24-36 months|Undetectable minimal residual disease (MRD) in the peripheral blood (PB)., Use residual disease (MRD) assays in the peripheral blood (PB)., 24-36 months|Safety and adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE)., Safety and adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE)., 24-36 months|Overall response rate (ORR), per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria, 2018., Overall response rate (ORR), per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria, 2018., 24 - 36 months|Measure financial toxicity (FT) in CLL/SLL patients, The addition of Venetoclax to BTKi for 12 months is anticipated to improve cancer-related fatigue as compared to use of BTKi alone in CLL/SLL patients. FACT-COST PRO instrument will be used. The score ranges between 0 and 44, and a higher score implies better financial well-being., 24-36 months|CLL/SLL patients' experience through patient reported outcome (PRO) QoL, The addition of Venetoclax to BTKi for 12 months is anticipated to improve of cancer-related fatigue as compared to use of BTKi alone in CLL/SLL patients. Aggregate scores from PRO instruments (QLQ-C30, QLQ-CLL17) will be used. These multi-item scales range in score from 0 to 100. A high score on these scales represents a high level of symptomatology or problems., 24-36 months