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.
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 a "Bruton Tyrosine Kinase Inhibitor" or BTKi. Another treatment for CLL/SLL is a different pill called venetoclax. People with CLL/SLL who are currently taking BTKi as their treatment must continue to take the medicine for the rest of their lives (unless it is no longer working or causing difficult side effects). New studies tested the combination of BTKi and venetoclax for one to two years, and showed that it was a very effective treatment, and allowed patients to stop therapy. The investigators don't know if adding venetoclax in patients who have already taken BTKi therapy for at least six months and who are responding to it will help control the CLL/SLL better and if it will allow them to stop treatment safely. Also, the investigators don't know how the side effects and effectiveness of the combination will be in Veterans. The investigators also don't know how a patient's quality of life will be affected if they continue BTKi by itself or if they take the combination and then are able to stop treatment. If participants meet the eligibility criteria, they will be randomly assigned a study treatment. This study has 2 main study groups: ARM A (BTKI ALONE): There will be about 50 people in this group. ARM B (BTKI PLUS VENETOCLAX): There will be about 50 people in this group. The participants will not be charged for any treatments or procedures that are part of this study. If participants usually pay co-payments for VA care and medications, they will still pay these co-payments for VA care and medications that are not part of this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
IMBRUVICA is a kinase inhibitor Acalabrutinib is a selective, irreversible small molecule inhibitor of BTK. Zanubrutinib is BTK inhibitors
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States
RECRUITINGKansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, United States
RECRUITINGDurham VA Medical Center, Durham, NC
Durham, North Carolina, United States
RECRUITINGVA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States
RECRUITINGThe 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.
Time frame: 24-36 months
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.
Time frame: 24-36 months
Undetectable minimal residual disease (MRD) in the peripheral blood (PB).
Use residual disease (MRD) assays in the peripheral blood (PB).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24-36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.