The main objective of this study is to evaluate the efficacy of the combination of
venetoclax plus ibrutinib for treating adults with T-cell prolymphocytic leukemia
(T-PLL).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03873493.
This study is planned as an adaptive 2-stage design as follows:
Stage 1: Enroll 14 participants with relapsed or refractory (R/R) T-PLL and move to Stage
2 if 4 or more participants meet protocol-specified response criteria. Response
assessment will be performed on a continued basis until all 14 participants have enrolled
into Stage 1 and have completed the Week 24 disease assessment.
Stage 2: Enroll up to an additional 23 participants.
The study was stopped after Stage 1. Stage 2 was not conducted.