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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

Withdrawn Phase 1 Last updated 9 January 2018
What this trial tests

Phase 1 trial testing Venetoclax in Leukemia, Lymphocytic, Chronic, B-Cell. Withdrawn.

Timeline
17 January 2018
Primary endpoint
25 May 2018
25 November 2020

Quick facts

Lead sponsorBoehringer Ingelheim
PhasePhase 1
StatusWithdrawn
Study typeINTERVENTIONAL
Designparallel
Maskingnone
Primary purposetreatment
Start date17 January 2018
Primary completion25 May 2018
Estimated completion25 November 2020

Drugs / interventions tested

Conditions studied

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Leukemia, Lymphocytic, Chronic, B-Cell. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Venetoclax

Trials testing the same drug.

Other recruiting trials for Leukemia, Lymphocytic, Chronic, B-Cell

Currently open trials in the same condition.

Other Boehringer Ingelheim trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03343678.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing