Overview

This trial is active, not recruiting.

Condition chronic lymphocytic leukemia
Treatment abt-199
Phase phase 2
Target BCL-2
Sponsor AbbVie
Collaborator Genentech/Roche
Start date September 2014
End date October 2017
Trial size 120 participants
Trial identifier NCT02141282, M14-032

Summary

This is an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacy and safety of ABT-199 in approximately 120 subjects with relapsed or refractory CLL after B-cell receptor signaling pathway inhibitors (BCR PI) treatment.

United States California, District of Columbia, Georgia, Illinois, Massachusetts, New York, Ohio, Texas, and Utah
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Single daily doses increasing weekly as tolerated
abt-199
ABT-199 monotherapy
(Experimental)
Single daily doses increasing weekly as tolerated
abt-199
ABT-199 monotherapy
(Experimental)
Single daily doses increasing weekly as tolerated
abt-199
ABT-199 monotherapy

Primary Outcomes

Measure
Overall response rate (ORR)
time frame: Measured up to 2 years after the last subject has enrolled in the study.

Secondary Outcomes

Measure
Duration of response
time frame: Measured up to 2 years after the last subject has enrolled in the study.
Time to progression (TTP)
time frame: Measured up to 5 years after the last subject has enrolled in the study.
Progression-free survival (PFS)
time frame: Measured up to 5 years after the last subject has enrolled in the study.
Overall survival (OS)
time frame: Measured up to 5 years after the last subject has enrolled in the study.

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: - Subject must have a diagnosis of CLL that meets 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (iwCLL NCI-WG) criteria - Subject has relapsed/refractory disease with an indication for treatment - Subject has refractory disease or developed recurrence after therapy with a BCR PI - Subject must have an Eastern Cooperative Oncology Group performance score of equal to or less than 2 - Subject must have adequate bone marrow function at Screening - Subject must have adequate coagulation profile, renal, and hepatic function, per laboratory reference range at Screening Exclusion Criteria: - Subject has undergone an allogeneic stem cell transplant within the past year - Subject has developed Richter's transformation confirmed by biopsy - Subject has active and uncontrolled autoimmune cytopenia - Subject has malabsorption syndrome or other condition that precludes enteral route of administration - Subject is human immunodeficiency virus (HIV) positive or has chronic hepatitis B or hepatitis C virus requiring treatment - Subject has known contraindication or allergy to both xanthine oxidase inhibitors and rasburicase.

Additional Information

Official title A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.