Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

• Status: Active, not recruiting
• Trial end date: 2023-04-03
• Target enrollment: 0
• Participant gender: All

Summary

An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib versus Chlorambucil)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmacyclics LLC.
• Collaborator: Janssen Research & Development, LLC
• Treatments: Chlorambucil

Criteria

Inclusion Criteria:

1. Randomized in the parent study, PCYC-1115-CA

2. Informed consent for Study PCYC-1116-CA

3. IRC-confirmed PD in the parent study PCYC-1115-CA or closure of the parent study

Exclusion Criteria:

1. Disease progression involving the central nervous system (CNS) or transformation to another histology

2. Intervening chemotherapy, immunotherapy, or investigational agent specifically to treat CLL if administered before date of IRC confirmed progressive disease

3. In the 4 weeks before dosing: radiation therapy, major surgery, or receipt of an investigational drug

4. Requirement for treatment with a strong CYP3A inhibitor

5. Uncontrolled systemic infection or requirement for IV antibiotics

6. Noncompliance on the parent study(PCYC-1115-CA)