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#
Status
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
- * 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
- * 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
Investigator(s)
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Contact
CCTO
650-498-7061
View on ClinicalTrials.gov