An Extension Study for Subjects Who Are Deriving Benefit With Idelalisib (GS-1101; CAL-101) Following Completion of a Prior Idelalisib Study
- Conditions
- Chronic Lymphocytic LeukemiaLymphoma, Non-Hodgkin
- Interventions
- Registration Number
- NCT01090414
- Lead Sponsor
- Gilead Sciences
- Brief Summary
This is a long-term safety extension study of idelalisib (GS-1101; CAL-101) in patients with hematologic malignancies who complete other idelalisib studies. It provides the opportunity for patients to continue treatment as long as the patient is deriving clinical benefit. Patients will be followed according to the standard of care as appropriate for their type of cancer. The dose of idelalisib will generally be the same as the dose that was administered at the end of the prior study, but may be titrated up to improve clinical response or down for toxicity. Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion of the investigator.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 202
- Patients with hematologic malignancies completing a prior idelalisib study with a clinical benefit are eligible
- Women of childbearing potential must have a negative pregnancy test to be eligible
- Male patients, and female patients of childbearing potential, must agree to use method(s) of contraception specified in the protocol
Key
- Patients who are unwilling or unable to comply with the protocol are not eligible
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Idelalisib Idelalisib Participants will receive up to 350 mg of idelalisib twice daily until disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Overall Response Rate Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) Overall response rate (ORR) was defined as the percentage of participants who achieve complete response (CR), partial response (PR), or minor response (MR; for lymphoplasmacytic lymphoma/Waldenström's macroglobulinemia (LPL/WM) only).
Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Events Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) plus 30 days
- Secondary Outcome Measures
Name Time Method Duration of Response Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) Duration of response (DOR) was defined as the interval from the first documentation of CR, PR, or MR (for LPL/WM) to the earlier of the first documentation of disease progression or death from any cause. DOR was analyzed using Kaplan-Meier (KM) estimates.
Progression-Free Survival Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) Progression-free survival (PFS) was defined as the interval from start of idelalisib treatment in the parent study to the earlier of the first documentation of disease progression or death from any cause. PFS was analyzed using KM estimates.
Overall Survival Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) Overall survival (OS) was defined as the interval from the start of study treatment in the parent study to death from any cause. OS was analyzed using KM estimates.
Time to Response Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) Time to response (TTR) was defined as the interval from start of study treatment to the first documentation of CR, PR, or MR (for LPL/WM). Analysis only includes participants who achieved complete or partial response (or minor response for LPL/WM participants). No participants in the 101-02 (AML and MM) groups achieved a complete or partial response.
Trial Locations
- Locations (18)
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Willamette Valley Cancer Institute and Research Center
🇺🇸Springfield, Oregon, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Clearview Cancer Institute
🇺🇸Huntsville, Alabama, United States
Stanford Cancer Center
🇺🇸Palo Alto, California, United States
UCLA
🇺🇸Los Angeles, California, United States
Center for Cancer & Blood Disorders, PC
🇺🇸Bethesda, Maryland, United States
Long Island Jewish medical Center
🇺🇸New Hyde Park, New York, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Weill Medical College of Cornell
🇺🇸New York, New York, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Yakima Regional Cancer Care
🇺🇸Yakima, Washington, United States
MD Anderson Cancer and Research Center
🇺🇸Houston, Texas, United States