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

Not Recruiting

Trial ID: NCT02141282

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

Stanford Investigator(s)

Rondeep Brar
Rondeep Brar

Clinical Associate Professor, Medicine - Hematology

Caroline Berube
Caroline Berube

Clinical Associate Professor, Medicine - Hematology

Eligibility


Inclusion 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

Exclusion Criteria:

   - 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

Intervention(s):

drug: Venetoclax

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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