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 Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion of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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
202
Idelalisib tablets or capsules administered orally
Clearview Cancer Institute
Huntsville, Alabama, United States
UCLA
Los Angeles, California, United States
Stanford Cancer Center
Palo Alto, California, United States
Center for Cancer & Blood Disorders, PC
Bethesda, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Long Island Jewish medical Center
New Hyde Park, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Weill Medical College of Cornell
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
...and 8 more locations
Overall Response Rate
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).
Time frame: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)
Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Events
Time frame: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) plus 30 days
Duration of Response
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.
Time frame: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)
Progression-Free Survival
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.
Time frame: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)
Overall Survival
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 frame: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)
Time to Response
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.
Time frame: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)
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