NCT03343678

This Study in Patients With Chronic Lymphocytic Leukaemia is Done to Determine a Safe and Effective Dose of BI 836826 in Combination With Venetoclax

An Open-label, Multi-centre, Phase Ib Trial to Determine the Dose of Intravenous BI 836826 in Combination With Oral Venetoclax in Chronic Lymphocytic Leukaemia Patients Who Are Eligible for Treatment With Venetoclax

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this trial is to determine the maximum tolerated dose (MTD) of BI 836826 in combination with venetoclax on the basis of dose limiting toxicities (DLTs incidence rate during the MTD evaluation period of the combination treatment and to determine the recommended Phase II dose (RP2D) of the combination. Other objectives are to evaluate the pharmacokinetics of BI 836826 in combination with venetoclax and to further determine the safety, as well as to evaluate the efficacy of the combination by means of the Complete Response (CR) rate and Minimal Residual Disease (MRD) negativity rate.

Conditions

• Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Type	Name	Description
DRUG	Venetoclax	Venetoclax given alone and then in combination with BI 836826
DRUG	BI 836826	Venetoclax given in combination with BI 836826

Timeline

• Start date: 2018-01-17
• Primary completion: 2018-05-25
• Completion: 2020-11-25
• First posted: 2017-11-17
• Last updated: 2018-01-09