Intermittent Therapy With the BTK Inhibitor Acalabrutinib (Calquence) in Combination With Obinutuzumab in Treatment Naive (Tn) Patients With Chronic Lymphocytic Leukemia (CLL)
M.D. Anderson Cancer Center
Summary
This phase II trial investigates the how well acalabrutinib and obinutuzumab work in treating patients with chronic lymphocytic leukemia (CLL). Acalabrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving acalabrutinib and obinutuzumab may help to control disease progression in CLL patients who have not received treatment for CLL.
Description
PRIMARY OBJECTIVE: • to determine the proportion of patients who have treatment-free remission 6 months after discontinuation of acalabrutinib plus obinutuzumab therapy. SECONDARY OBJECTIVES: * to determine clinical factors associated with a treatment-free remission of more than 6 months after discontinuation of acalabrutinib; * to determine the treatment-free remission length; * to evaluate the efficacy of re-treatment with acalabrutinib plus obinutuzumab in patients who experience disease relapse. EXPLORATORY OBJECTIVES: • to characterize the effects of limited duration acalabrutinib pl…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis CLL/small lymphocytic lymphoma (SLL) and be untreated * Patients must have an indication for treatment by 2018 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Patients of childbearing potential must be willing to practice highly effective birth control during treatment and for 2 days after the last dose of acalabrutinib or 18 months after the last dose of obinutuzumab, whichever is later * A negative urine pregnancy test (within 7 days of day 1) is required for women…
Interventions
- DrugAcalabrutinib
Given PO
- BiologicalObinutuzumab
Given IV
Location
- M D Anderson Cancer CenterHouston, Texas