Non-interventional Study to Assess the Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma (FL)

Gilead Sciences88 sites in 6 countries257 target enrollmentMay 25, 2018

ConditionsFollicular Non-Hodgkin's Lymphoma Refractory

InterventionsIdelalisib

DrugsIdelalisib

Overview

Phase: Not Applicable
Intervention: Idelalisib
Conditions: Follicular Non-Hodgkin's Lymphoma Refractory
Sponsor: Gilead Sciences
Enrollment: 257
Locations: 88
Primary Endpoint: Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AE), Serious AEs, Special Situation Reports, Adverse Drug Reactions (ADR), and Serious ADRs
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to assess the overall safety profile of idelalisib monotherapy in patients with refractory follicular lymphoma (FL).

Registry

clinicaltrials.gov

Start Date

May 25, 2018

End Date

October 29, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Gilead Sciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Individuals who were or are being treated for refractory Follicular Lymphoma (FL) according to the product information for idelalisib and treatment guidelines in routine clinical practice.

Exclusion Criteria

•Individuals included in clinical trials on idelalisib within the timeframe of this study.

Arms & Interventions

Idelalisib

Participants who have been or are currently being treated with 100 or 150 mg of idelalisib

Intervention: Idelalisib

Outcomes

Primary Outcomes

Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AE), Serious AEs, Special Situation Reports, Adverse Drug Reactions (ADR), and Serious ADRs

Time Frame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)

Secondary Outcomes

Duration of Response (DOR)(250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period))
Time to Next Treatment (TTNT)(250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period))
Overall Survival (OS)(250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period))
Overall Response Rate (ORR)(250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period))
Progression-free Survival (PFS)(250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period))