Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma

• Status: Active, not recruiting
• Trial end date: 2023-03-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, 2-cohort Phase 2 study assessing both MRD-guided discontinuation and fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with treatment-naïve CLL or SLL

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

Details

• Lead Sponsor: Pharmacyclics LLC.
• Collaborators: Janssen Research & Development, LLC; Janssen Research and Development LLC
• Treatments: Venetoclax

Criteria

Inclusion Criteria:

• Diagnosis of CLL/SLL that meets IWCLL diagnostic criteria (Hallek 2008), with active disease meeting at least 1 IWCLL criteria for requiring treatment.

• Measurable nodal disease by computed tomography (CT)

• Adequate hepatic, and renal function

• Adequate hematologic function

• absolute neutrophil count >750/µL

• platelet count >30,000 /μL

• hemoglobin >8.0 g/dL

Exclusion Criteria:

• Any prior therapy used for treatment of CLL/SLL

• Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects at risk for TLS