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 No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Primary purpose treatment
Masking no masking
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

All 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 January 2017.
Information provided to ClinicalTrials.gov by AbbVie.