Gene Therapy Clinical Trials
Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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)
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: Alternative Anticancer Treatment
- drug: Post-Chlorambucil Therapy Follow-up
- drug: Ibrutinib
- drug: Second-line Ibrutinib
- drug: Alternative Anti-cancer Treatment
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)
Ages Eligible for Study
65 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting