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

Sponsor
Boehringer Ingelheim
Study ID
NCT03343678
Phase
PHASE1
Status
Withdrawn

Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Venetoclax given alone and then in combination with BI 836826
  • BI 836826 — DRUG
    Venetoclax given in combination with BI 836826

Study Details

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.

Key Dates

Start date
Jan 17, 2018
Status verified
Jan 2018
Primary completion
May 25, 2018
Completion
Nov 25, 2020

Study Design

Enrollment
0 participants (actual)
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax + BI 836826

Primary Outcome Measure

Maximum tolerated dose (MTD) based on the number of patients with dose limiting toxicities (DLTs) in the MTD evaluation period [ Time Frame: up to 28 days ]

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