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

Leukemia, Lymphocytic, Chronic, B-Cell Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03343678
Study type Interventional
Source Boehringer Ingelheim
Contact
Status Withdrawn
Phase Phase 1
Start date January 17, 2018
Completion date November 25, 2020
View Details
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