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

• Status: Active, not recruiting
• Trial end date: 2021-12-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Collaborators: Genentech/Roche; Roche-Genentech
• Treatments: Idelalisib; Receptors, Antigen, B-Cell; Venetoclax

Criteria

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.