NCT03873493

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Leukemia
• T-cell Prolymphocytic Leukemia (T-PLL)
• Cancer

Interventions

Type	Name	Description
DRUG	Venetoclax	Venetoclax tablets taken orally once a day (QD). Initially, venetoclax was administered utilizing a 5-step dose ramp-up over 5 days. Subjects were hospitalized and closely monitored for 7 days. The venetoclax ramp-up was administered in a daily manner: 20 mg on Week 1 Day 1, 50 mg on Week 1 Day 2, 100 mg on Week 1 Day 3, 200 mg on Week 1 Day 4, and 400 mg on Week 1 Day 5 and thereafter, once daily, until the end-of-treatment. The dose of venetoclax may have been increased to 600 mg QD at Week 8 or thereafter.
DRUG	Ibrutinib	Ibrutinib capsules taken orally once a day, 420 mg/day until the end-of-treatment.

Timeline

• Start date: 2020-01-14
• Primary completion: 2021-11-04
• Completion: 2021-11-04
• First posted: 2019-03-13
• Last updated: 2022-12-19
• Results posted: 2022-12-19

Locations

15 sites across 9 countries: United States, Australia, Austria, Finland, France, Germany, Italy, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study