A Phase 2 Study of Venetoclax and Romidepsin with Safety Lead-in for Treatment of Relapsed/ Refractory Mature T-cell Lymphomas
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/Chronic lymphocytic leukemia (CLL)
Current Status: Open to accrual
Phase: II
Principal Investigator: Lunning, Matthew
Contact Information:
Sarah Snook
sarah.snook@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT03534180?cond=NCT03534180&draw=2&rank=1#eligibility
Summary
PRIMARY OBJECTIVES: I. To assess the safety and tolerability of the combination of venetoclax with romidepsin, including the dose ramp-up, in adults with relapsed or refractory mature T-cell lymphoma. (Safety Lead-in) II. To estimate the efficacy as measured by the overall response rate [ORR]) of venetoclax with romidepsin in patients with relapsed or refractory mature T-cell lymphoma. (Phase 2)
SECONDARY OBJECTIVES: I. To evaluate the complete response rate, duration of response, time to response, overall survival and progression free survival associated with venetoclax and romidepsin in relapsed/refractory mature T-cell lymphoma. (Phase 2) II. To further characterize the safety and toxicities of venetoclax and romidepsin combination in relapsed/refractory mature T-cell lymphoma. (Phase 2)
EXPLORATORY OBJECTIVES: I. BCL2 protein expression in baseline treatment tumor samples and correlation with response II. To determine changes in Bcl-2 gene expression in pre- and post-treatment tumor samples of mature T- cell lymphoma.