Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma
- Registration Number
- NCT03568929
- Lead Sponsor
- Gilead Sciences
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 257
- 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.
- Individuals included in clinical trials on idelalisib within the timeframe of this study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Idelalisib Idelalisib Participants who have been or are currently being treated with 100 or 150 mg of idelalisib
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
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.
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.
Trial Locations
- Locations (88)
Ziekenhuis Netwerk Antwerpen Stuivenberg Hospital
🇧🇪Antwerpen, Belgium
Centre Hospitalier Universitaire d'Amiens (CHU d'Amiens) - Hopital Nord
🇫🇷Amiens Cedex 1, France
Centre Hospitalier Bourg-en-Bresse Fleyriat
🇫🇷Bourg-en-Bresse, France
Centre Hospitalier de Cannes
🇫🇷Cannes, France
Hôpital Privé Sévigné
🇫🇷Cesson-Sevigne, France
Centre Hospitalier Chalon sur Saône William Morey
🇫🇷Chalon-Sur-Saone, France
Centre Hospitalier Universitaire Estaing
🇫🇷Clermont-Ferrand, France
CHU de Dijon
🇫🇷Dijon, France
Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard
🇫🇷Grenoble, France
Clinique Victor Hugo
🇫🇷Le Mans Cedex 2, France
Scroll for more (78 remaining)Ziekenhuis Netwerk Antwerpen Stuivenberg Hospital🇧🇪Antwerpen, Belgium