©2022 Stanford Medicine
Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Not Recruiting
Trial ID: NCT01724346
Purpose
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)
Official Title
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)
Eligibility
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)
Intervention(s):
drug: Alternative Anticancer Treatment
drug: Post-Chlorambucil Therapy Follow-up
drug: Ibrutinib
drug: Second-line Ibrutinib
drug: Alternative Anti-cancer Treatment
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061