A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy

Trial ID or NCT#

NCT02141282

Status

not recruiting iconNOT RECRUITING

Purpose

This was an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacy and safety of ABT-199 in 127 participants with relapsed or refractory chronic lymphocytic leukemia (CLL) after B-cell receptor signaling pathway inhibitors (BCR PI) treatment.

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Participant must have a diagnosis of chronic lymphocytic leukemia (CLL) that meets 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (IWCLL NCI-WG) criteria - Participant has relapsed/refractory disease with an indication for treatment - Participant has refractory disease or developed recurrence after therapy with a B-cell receptor pathway inhibitor (BCR PI) - Participant must have an Eastern Cooperative Oncology Group performance score of ≤ 2 - Participant must have adequate bone marrow function at Screening - Participant must have adequate coagulation profile, renal, and hepatic function, per laboratory reference range at Screening
Exclusion Criteria:
  1. - Participant has undergone an allogeneic stem cell transplant within the past year - Participant has developed Richter's transformation confirmed by biopsy - Participant has active and uncontrolled autoimmune cytopenia - Participant has malabsorption syndrome or other condition that precludes enteral route of administration - Participant is human immunodeficiency virus (HIV) positive or has chronic hepatitis B or hepatitis C virus requiring treatment - Participant has known contraindication or allergy to both xanthine oxidase inhibitors and rasburicase
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Investigator(s)

Rondeep Brar
Rondeep Brar
Hematologist-Oncologist
Clinical Associate Professor, Medicine - Hematology
Caroline Berube
Caroline Berube
Hematologist-Oncologist
Clinical Associate Professor, Medicine - Hematology

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Contact

CCTO
650-498-7061

View on ClinicalTrials.gov