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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)


Phase 3
65 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Thank you

Trial Information

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)


Study PCYC-1116-CA is an open-label, multicenter extension of Study PCYC 1115-CA
(RESONATEā„¢-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.


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:

- N/A

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

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
MD Anderson Cancer CenterHouston, Texas  77030-4096
City of Hope National Medical CenterLos Angeles, California  91010
Stanford Cancer CenterStanford, California  94305-5824
University of RochesterRochester, New York  14642
Washington UniversitySt. Louis, Missouri  63110
UPMC Cancer PavilionPittsburgh, Pennsylvania  15232
Peachtree Hematology Oncology ConsultantsAtlanta, Georgia  30309
CLL Research and Treatment ProgramNew Hyde Park, New York  11042
UCSD Medical Center Thorton HospitalLa Jolla, California  92307
University of Chicago - Oncology DeptChicago, Illinois  60637
Norton Cancer Institute - PavilionLouisville, Kentucky  40202
U Mass Memorial University CampusWorcester, Massachusetts  01655
Southeastern MedicalGoldsboro, North Carolina  27534
South Texas Research Alliance LLCLaredo, Texas  78041
Oncology of San AntonioSan Antonio, Texas  78240