Follicular Non-Hodgkin's Lymphoma Refractory
Conditions
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).
Interventions
DRUGIdelalisib
Tablets administered according to the product information and treatment guidelines in routine clinical practice
Sponsors
Gilead Sciences
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
| 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) | OS is defined as the interval from the date of initiation of idelalisib to death from any cause. |
Countries
Belgium, France, Germany, Greece, Ireland, Italy, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed