Clinical trial NCT03568929: Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma
Official title: Non-interventional Study to Assess the Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma (FL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Follicular Non-Hodgkin's Lymphoma Refractory
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2018-06-26
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who were or are being treated with idelalisib for refractory FL according to the product information and treatment guidelines in routine clinical practice after the country specific approval date.

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).


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.

Primary outcomes:
measure: 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
timeFrame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)
measure: Duration of Response (DOR)
timeFrame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)
measure: Progression-free Survival (PFS)
timeFrame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)
measure: Time to Next Treatment (TTNT)
timeFrame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)
measure: Overall Survival (OS)
timeFrame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen Stuivenberg Hospital
city: Amiens Cedex 1
country: France
facility: Centre Hospitalier Universitaire d'Amiens (CHU d'Amiens) - Hopital Nord
city: Bourg-en-Bresse
country: France
facility: Centre Hospitalier Bourg-en-Bresse Fleyriat
city: Cannes
country: France
facility: Centre Hospitalier de Cannes
city: Cesson-Sevigne
country: France
facility: Hôpital Privé Sévigné
city: Chalon-Sur-Saone
country: France
facility: Centre Hospitalier Chalon sur Saône William Morey
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire Estaing
city: Dijon
country: France
facility: CHU de Dijon
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard
city: Le Mans Cedex 2
country: France
facility: Clinique Victor Hugo
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
city: Lens
country: France
facility: Centre Hospitalier de Lens
city: Marseille
country: France
facility: Hôpital de la Conception
city: Orléans
country: France
facility: Centre Hospitalier Régional d'Orléans
city: Pessac
country: France
facility: Centre hospitalier de Perigueux
city: Pierre Bénite Cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers Cedex
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Tours
country: France
facility: Hopital Bretonneau, Centre Henri Kaplan
city: Frankfurt
country: Germany
facility: Klinikum Frankfurt Hochst
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Rostock
country: Germany
facility: Klinikum Südstadt Rostock
city: Westerstede
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis
city: Athens
country: Greece
facility: Athens Medical Center-Psychikon branch
city: Athens
country: Greece
facility: Henry Dunant Hospital
city: Patra
country: Greece
facility: University General Hospital of Patras
city: Thessaloniki
country: Greece
facility: AHEPA University General Hospital of Thessaloniki
city: Dublin
country: Ireland
facility: Saint James's Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Mullingar
country: Ireland
facility: Midland Regional Hospital - Mullingar
city: Ancona
country: Italy
facility: Ospedali Riuniti di Ancona, Clinica Ematologica
city: Ascoli Piceno
country: Italy
facility: Ospedale Mazzoni
city: Bari
country: Italy
facility: Azienda Ospedaliera Policlinico di Bari
city: Barletta
country: Italy
facility: Monsignor Raffaele Dimiccoli Hospital
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
city: Catania
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
city: Civitanova Marche
country: Italy
facility: Ospedale di Civitanova Marche
city: Florence
country: Italy
facility: Azienda Ospedaliero - Universitaria Careggi
city: Livorno
country: Italy
facility: Presidio Ospedaliero di Livorno
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Grande Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Istituto Scientifico Universitario San Raffaele
city: Novara
country: Italy
facility: Azienda Ospedaliera Universitaria Maggiore Della Carita di Novara
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia
city: Pesaro
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord
city: Piacenza
country: Italy
facility: Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
city: Ravenna
country: Italy
facility: Azienda Unita Sanitaria Locale di Ravenna
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Rionero in Vulture
country: Italy
facility: IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
city: Roma
country: Italy
facility: Universita degli Studi di Roma La Sapienza
city: Roma
country: Italy
facility: Istituti di Ricovero e Cura A Carattere Scientifico - Istituti Fisioterapici Ospitalieri
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese-L'ospedale Santa Maria alle Scotte
city: Vicenza
country: Italy
facility: Ospedale San Bortolo di Vicenza
city: Lisbon
country: Portugal
facility: Instituto Português de Oncologia Francisco Gentil, Centro Regional de Lisboa SA
city: Barcelona
country: Spain
facility: Fundació Hospital de la Santa Creu i Sant Pau
state: Cataluña
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Universitari Mútua Terrassa
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Gijon
country: Spain
facility: Hospital De Cabuenes
city: Gipuzkoa
country: Spain
facility: Hospital Universitario Donostia
city: L'Hospitalet de LLobregat
country: Spain
facility: Institut Català d'Oncologia
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital San Pedro de Alcantara
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Móstoles
country: Spain
facility: Hospital Universitario Rey Juan Carlos
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Dureta
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Valencia
country: Spain
facility: Hospital Universitari Arnau De Vilanova (Huav)
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital de Día Quirónsalud Zaragoza
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Cardiff
country: United Kingdom
facility: Velindre NHS Trust
city: London
country: United Kingdom
facility: St George's Healthcare NHS Trust
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospitals Nhs Foundation Trust
city: Swansea
country: United Kingdom
facility: Abertawe Bro Morgannwg University Health Board
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: