Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma

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

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

Conditions
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Follicular Non-Hodgkin's Lymphoma Refractory

Intervention / Treatment
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* Drug: Idelalisib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Idelalisib<br>Participants who have been or are currently being treated with 100 or 150 mg of idelalisib | Drug: Idelalisib<br>* Tablets administered according to the product information and treatment guidelines in routine clinical practice<br>* Other names: Zydelig®;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | ORR is defined as the proportion of participants who achieve a clinical response with or without radiological confirmation as documented within their electronic health record after the initiation of treatment with idelalisib and during the treatment period with idelalisib. | 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period) | 
| Duration of Response (DOR) | DOR is defined as the interval from the first documentation of a clinical response with or without radiological confirmation to the earlier of the first documentation of disease progression or death from any cause. | 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) | PFS is defined as the interval from the date of initiation of idelalisib to the earlier date of the first documentation of disease progression or death from any cause. | 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) | TTNT is defined as the interval from the initiation of treatment with idelalisib to the earlier date of the initiation of next systemic treatment of Follicular Lymphoma (excluding palliative care or palliative radiation) or death from any cause. | 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) | OS is defined as the interval from the date of initiation of idelalisib to death from any cause. | 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period) |