A Multicenter Parallel 2 Cohort Phase 2 Study of LP-168 and Obinutuzumab for Previously Treated, and T474 Gatekeeper Mutant Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and Variants of This
Zulfa Omer
Summary
Multicenter Parallel 2 Cohort Phase 2 Study of LP-168 and Obinutuzumab for Previously Treated, and T474 Gatekeeper Mutant Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and Variants of This.
Description
This is a multicenter parallel two cohort, phase II clinical trial designed to evaluate the combination of obinutuzumab + LP-168 for the treatment of: 1) previously treated, and 2) BTK T474I ( gate keeper mutation) mutated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) patients. The goal is to establish a safe dosing regimen for the combination and to acquire pilot data characterizing the effectiveness of the combination in increasing the depth of response as reflected in the rate of undetectable Minimal Residual Disease (MRD), complete response (CR). If successful, this wou…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis of CLL or SLL meeting criteria established in the 2018 iwCLL criteria and requiring treatment. Patients with variation in flow cytometry findings will be allowed to enroll if cytogenetics and/or mutational studies are supportive of CLL/SLL variant. a) Note: Variation in flow cytometry is defined as patients who have atypical immunophenotyping for CLL (CD5 negative, CD23 negative or surface expression of CD79b that is bright ) but clinically behave like CLL (leukocytosis, lymphadenopathy and splenomegaly) and have the FISH/Cytogenetics translocations(del 13…
Interventions
- DrugLP-168
Patients will receive LP-168 200 mg daily beginning day 1 of therapy for 12 cycles.
- DrugObinutuzumab
Patients will with LP-168 and then receive obinutuzumab for a total of 6 cycles, beginning cycle 7, days 1, 2, 8 and 15, and then day 1 of cycles 8-12. A minimum of 12 cycles of therapy will be administered.
Location
- University of Cincinnati Medical CenterCincinnati, Ohio