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

Phase 1

Withdrawn

• Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
• Interventions: Drug: Venetoclax; Drug: BI 836826

• Registration Number: NCT03343678
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2017-11-13
• Study First Posted: 2017-11-17
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-08
• Last Update Posted: 2018-01-09
• Study Start: 2018-01-17
• Primary Completion: 2018-05-25
• Study Completion: 2020-11-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Venetoclax + BI 836826	Venetoclax	-
Venetoclax + BI 836826	BI 836826	-

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) based on the number of patients with dose limiting toxicities (DLTs) in the MTD evaluation period	up to 28 days
Number of patients with dose limiting toxicities (DLTs) in the Maximum tolerated dose (MTD) evaluation period	up to 28 days

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time curve at steady-state (AUCtau) of BI 836826 when administered in combination with venetoclax with an observation time of 28 days in Cycle 1 of the combination.	up to 28 days
Complete response (CR) defined by investigator's assessment based on response assessment at imaging time points, analysed by complete response rate	up to 36 months
Minimal residual disease (MRD) negativity based on blood and analysed by MRD negativity rate	up to 36 months
Minimal residual disease (MRD) negativity based on bone marrow and analysed by MRD negativity rate	up to 36 months