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)

Exclusion Criteria

• •Prior treatment
• •Patients must not have progression of CLL/SLL on BTKi therapy prior to initiation of the study therapy.
• •Patients must not have received the combination of BTKi + venetoclax previously.
• •Comorbid conditions or other active diseases
• •Patients must not have any history of Richter's transformation or prolymphocytic leukemia.
• •If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable and be on suppressive therapy, if indicated.
• •Please note: IVIG can cause a false positive hepatitis B serology. If patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B DNA) they may still participate in the study, must have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician.
• •If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load.
• •Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy are eligible for this trial.
• •Concomitant medications
• •Patients must not be receiving active systemic anticoagulation with heparin or warfarin. Patients on warfarin must discontinue the drug for at least 10 days prior to registration on the study.
• •Chronic concomitant treatment with strong inhibitors of CYP3A4/5 is not recommended on this study. Patients on strong CYP3A inhibitors must discontinue the drug for 14 days prior to registration on the study or discuss with the study principal investigator.
• •Chronic concomitant treatment with strong CYP3A4/5 inducers is not recommended. Patients must discontinue the drug 14 days prior to registration on the study or discuss with the study principal investigator.
• •Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily.
• •Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics