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)
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)
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 (PCI-32765 Versus Chlorambucil)|
- PFS [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- 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
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||February 2018|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Alternative anticancer treatment is selected at the investigator's discretion. For a patient randomized to chlorambucil in the parent study PCYC-1115-CA, PCI-32765 is an option for second-line therapy, provided the patient meets the criteria for second-line PCI-32765 therapy. For a patient randomized to PCI-32765 in the parent study PCYC-1115-CA, the patient will continue on PCI-32765 at the parent study.
PCI-32765 will be supplied as hard gelatin 140-mg capsules for oral (PO) administration.PCI-32765 420 mg (3 x 140-mg capsules) is administered orally once daily. The first dose will be delivered in the clinic on Day 1, after which subsequent dosing is typically on an outpatient basis. PCI-32765 will be dispensed to patients in bottles at every other visit.
Study PCYC-1116-CA is an open-label, multicenter extension of Study PCYC 1115-CA (RESONATE™-2, the parent study), and it will run concurrently with the parent study. A patient will be transferred to PCYC-1116-CA after Independent Review Committee (IRC) confirmation of disease progression (PD) in the parent study or at closure of the parent study by the sponsor, whichever comes first.
After PD, selection of second-line therapy, when clinically indicated, is at the discretion of the investigator and can include second-line PCI-32765 (for patients randomized to chlorambucil in the parent study who also meet the criteria for second-line PCI-32765 therapy), second-line chlorambucil (for patients randomized to PCI-32765 in the parent study), or other therapies.
Assessments in the extension study vary depending on the treatment to which the patient was randomized in the parent study, the disease-progression status at transfer to the extension study, and the planned treatment in the extension study.