Trial ID or NCT#

NCT01889186

Status

not recruiting iconNOT RECRUITING

Purpose

This is a Phase 2, open label, multicenter, study evaluating the efficacy and safety of ABT-199 (Venetoclax) in relapsed or refractory subjects with CLL harboring 17p13 (TP53 locus) deletion. One hundred seven (107) subjects were enrolled in the main cohort, with evaluation of efficacy as the primary objective, and approximately 50 subjects will be enrolled in the safety expansion cohort to evaluate safety and updated tumor lysis syndrome prophylaxis and management measures. Enrollment into the main cohort is closed. Enrollment into the safety expansion cohort is closed.

Official Title

A Phase 2 Open-Label Study of the Efficacy of ABT-199 (GDC-0199) in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia Harboring the 17p Deletion

Eligibility Criteria

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Steven Coutre

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CONTACT

CCTO
(650) 498-7061