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 (PCI-32765 Versus Chlorambucil)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PFS

Outcome Description:

Progression Free Survial on first-line therapy for those patients who did not experience PD in the parent study Progression Free Survial on second-line anticancer therapy Overall survival For patients who discontinued first-line therapy, time from the end of firstline therapy to the beginning of second-line therapy Overall Response Rate, DOR, Progression Free Survial, and Overall survial on subsequent therapy for patients progressing in the parent study Safety as measured by Grade 3, 4, 5 AEs, AEs leading to discontinuation, and serious adverse events (SAEs) Disease outcome following cessation of PCI-32765 treatment after attainment of minimal residual disease (MRD)-negative remission in those patients receiving PCI-32765 as second-line therapy

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Alvina Chu, MD

Investigator Role:

Study Director

Investigator Affiliation:

Pharmacyclics

Authority:

United States: Food and Drug Administration

Study ID:

PCYC-1116-CA

NCT ID:

NCT01724346

Start Date:

January 2013

Completion Date:

February 2018

Related Keywords:

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma
• CLL, SLL
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma