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

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