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A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia

Cancer Clinical Trial

Official title:
A Prospective, Open-Label, Single-Arm, Phase 2, Multicenter Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects With T-Cell Prolymphocytic Leukemia

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03873493
Study type Interventional
Source AbbVie
Contact
Status Completed
Phase Phase 2
Start date January 14, 2020
Completion date November 4, 2021
View Details
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