Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma

NCT03568929 | Completed

• 2 other identifiers: GS-EU-313-4172EUPAS19618
• Study Type: observational
• Target: 257
• Locations: 10 countries
• Sites: 88

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).

Conditions

Follicular Non-Hodgkin's Lymphoma Refractory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

Idelalisib

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

Drug: Idelalisib

Interventions

Idelalisib DRUG

Tablets administered according to the product information and treatment guidelines in routine clinical practice

Also known as: Zydelig®

Idelalisib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (88)

Ziekenhuis Netwerk Antwerpen Stuivenberg Hospital

Antwerp, 2060, Belgium

Location

Centre Hospitalier Universitaire d'Amiens (CHU d'Amiens) - Hopital Nord

Amiens, 80054, France

Location

Centre Hospitalier Bourg-en-Bresse Fleyriat

Bourg-en-Bresse, France

Location

Centre Hospitalier de Cannes

Cannes, 06400, France

Location

Hôpital Privé Sévigné

Cesson-Sévigné, France

Location

Centre Hospitalier Chalon sur Saône William Morey

Chalon-sur-Saône, 71100, France

Location

Centre Hospitalier Universitaire Estaing

Clermont-Ferrand, 63003, France

Location

CHU de Dijon

Dijon, 2100, France

Location

Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard

Grenoble, France

Location

Clinique Victor Hugo

Le Mans, 72015, France

Location

Centre Hospitalier Le Mans

Le Mans, 72037, France

Location

Centre Hospitalier de Lens

Lens, 62300, France

Location

Hôpital de la Conception

Marseille, 13005, France

Location

Centre Hospitalier Régional d'Orléans

Orléans, 45650, France

Location

Centre hospitalier de Perigueux

Pessac, 33604, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86021, France

Location

Hopital Bretonneau, Centre Henri Kaplan

Tours, Cedex 37044, France

Location

Klinikum Frankfurt Hochst

Frankfurt, 65929, Germany

Location

Universitätsmedizin Göttingen

Göttingen, 37075, Germany

Location

Klinikum Südstadt Rostock

Rostock, Germany

Location

Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede

Westerstede, 26655, Germany

Location

University General Hospital of Alexandroupolis

Alexandroupoli, 68100, Greece

Location

Athens Medical Center-Psychikon branch

Athens, 11525, Greece

Location

Henry Dunant Hospital

Athens, 11526, Greece

Location

University General Hospital of Patras

Pátrai, 265 04, Greece

Location

AHEPA University General Hospital of Thessaloniki

Thessaloniki, 54636, Greece

Location

Saint James's Hospital

Dublin, 8, Ireland

Location

Mater Misericordiae University Hospital

Dublin, Dublin 7, Ireland

Location

Midland Regional Hospital - Mullingar

Mullingar, Ireland

Location

Ospedali Riuniti di Ancona, Clinica Ematologica

Ancona, 60126, Italy

Location

Ospedale Mazzoni

Ascoli Piceno, Italy

Location

Azienda Ospedaliera Policlinico di Bari

Bari, 70124, Italy

Location

Monsignor Raffaele Dimiccoli Hospital

Barletta, 70051, Italy

Location

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi

Catania, 95122, Italy

Location

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

Catania, 95124, Italy

Location

Ospedale di Civitanova Marche

Civitanova Marche, Italy

Location

Azienda Ospedaliero - Universitaria Careggi

Florence, 50134, Italy

Location

Presidio Ospedaliero di Livorno

Livorno, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, 47014, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20100, Italy

Location

Fondazione IRCCS Cà Grande Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Istituto Scientifico Universitario San Raffaele

Milan, 20132, Italy

Location

Azienda Ospedaliera Universitaria Maggiore Della Carita di Novara

Novara, 28100, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Azienda Ospedaliera di Perugia

Perugia, 06129, Italy

Location

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Pesaro, 61122, Italy

Location

Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto

Piacenza, Italy

Location

Azienda Unita Sanitaria Locale di Ravenna

Ravenna, 48121, Italy

Location

Arcispedale Santa Maria Nuova

Reggio Emilia, 42123, Italy

Location

IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture

Rionero in Vulture, 85028, Italy

Location

Universita degli Studi di Roma La Sapienza

Roma, 00161, Italy

Location

Istituti di Ricovero e Cura A Carattere Scientifico - Istituti Fisioterapici Ospitalieri

Roma, Italy

Location

Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, 71013, Italy

Location

Azienda Ospedaliera Universitaria Senese-L'ospedale Santa Maria alle Scotte

Siena, 53100, Italy

Location

Ospedale San Bortolo di Vicenza

Vicenza, Italy

Location

Instituto Português de Oncologia Francisco Gentil, Centro Regional de Lisboa SA

Lisbon, 1090-023, Portugal

Location

Fundació Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 8025, Spain

Location

Hospital General Universitario de Alicante

Alicante, 3011, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital Universitari Mútua Terrassa

Barcelona, 8221, Spain

Location

Hospital Universitario de Burgos

Burgos, 09006, Spain

Location

Hospital De Cabuenes

Gijón, 33394, Spain

Location

Hospital Universitario Donostia

Gipuzkoa, 20014, Spain

Location

Institut Català d'Oncologia

L'Hospitalet de Llobregat, Spain

Location

Hospital Universitario Severo Ochoa

Leganés, 28911, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital San Pedro de Alcantara

Madrid, 28009, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital Universitario Rey Juan Carlos

Móstoles, Spain

Location

Hospital General Universitario Morales Meseguer

Murcia, 30008, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33004, Spain

Location

Hospital Universitario Son Dureta

Palma de Mallorca, Spain

Location

Clínica Universidad de Navarra

Pamplona, 31008, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, 38320, Spain

Location

Hospital Universitari Arnau De Vilanova (Huav)

Valencia, 46015, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Hospital de Día Quirónsalud Zaragoza

Zaragoza, 50012, Spain

Location

Karolinska Universitetssjukhuset

Stockholm, 141 86, Sweden

Location

Velindre NHS Trust

Cardiff, United Kingdom

Location

St George's Healthcare NHS Trust

London, SW17 0QT, United Kingdom

Location

South Tees Hospitals Nhs Foundation Trust

Middlesbrough, TS4 3BW, United Kingdom

Location

Abertawe Bro Morgannwg University Health Board

Swansea, SA2 8QA, United Kingdom

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

idelalisib

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 26, 2018
• Study Start: May 25, 2018
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2021
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); FR (17); IT (27); DE (4); PT (1); IE (3); ES (25); GB (4); SE (1); GR (5)