Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma

NCT ID: NCT03568929

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

257 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-25

Study Completion Date

2021-10-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Follicular Non-Hodgkin's Lymphoma Refractory

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Idelalisib

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

Idelalisib

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Idelalisib

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zydelig®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ziekenhuis Netwerk Antwerpen Stuivenberg Hospital

Antwerp, , Belgium

Site Status

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

Amiens, , France

Site Status

Centre Hospitalier Bourg-en-Bresse Fleyriat

Bourg-en-Bresse, , France

Site Status

Centre Hospitalier de Cannes

Cannes, , France

Site Status

Hôpital Privé Sévigné

Cesson-Sévigné, , France

Site Status

Centre Hospitalier Chalon sur Saône William Morey

Chalon-sur-Saône, , France

Site Status

Centre Hospitalier Universitaire Estaing

Clermont-Ferrand, , France

Site Status

CHU de Dijon

Dijon, , France

Site Status

Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard

Grenoble, , France

Site Status

Clinique Victor Hugo

Le Mans, , France

Site Status

Centre Hospitalier Le Mans

Le Mans, , France

Site Status

Centre Hospitalier de Lens

Lens, , France

Site Status

Hôpital de la Conception

Marseille, , France

Site Status

Centre Hospitalier Régional d'Orléans

Orléans, , France

Site Status

Centre hospitalier de Perigueux

Pessac, , France

Site Status

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

Centre Hospitalier Universitaire de Poitiers

Poitiers, , France

Site Status

Hopital Bretonneau, Centre Henri Kaplan

Tours, , France

Site Status

Klinikum Frankfurt Hochst

Frankfurt, , Germany

Site Status

Universitätsmedizin Göttingen

Göttingen, , Germany

Site Status

Klinikum Südstadt Rostock

Rostock, , Germany

Site Status

Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede

Westerstede, , Germany

Site Status

University General Hospital of Alexandroupolis

Alexandroupoli, , Greece

Site Status

Athens Medical Center-Psychikon branch

Athens, , Greece

Site Status

Henry Dunant Hospital

Athens, , Greece

Site Status

University General Hospital of Patras

Pátrai, , Greece

Site Status

AHEPA University General Hospital of Thessaloniki

Thessaloniki, , Greece

Site Status

Saint James's Hospital

Dublin, , Ireland

Site Status

Mater Misericordiae University Hospital

Dublin, , Ireland

Site Status

Midland Regional Hospital - Mullingar

Mullingar, , Ireland

Site Status

Ospedali Riuniti di Ancona, Clinica Ematologica

Ancona, , Italy

Site Status

Ospedale Mazzoni

Ascoli Piceno, , Italy

Site Status

Azienda Ospedaliera Policlinico di Bari

Bari, , Italy

Site Status

Monsignor Raffaele Dimiccoli Hospital

Barletta, , Italy

Site Status

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, , Italy

Site Status

Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi

Catania, , Italy

Site Status

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

Catania, , Italy

Site Status

Ospedale di Civitanova Marche

Civitanova Marche, , Italy

Site Status

Azienda Ospedaliero - Universitaria Careggi

Florence, , Italy

Site Status

Presidio Ospedaliero di Livorno

Livorno, , Italy

Site Status

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, , Italy

Site Status

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

Site Status

Fondazione IRCCS Cà Grande Ospedale Maggiore Policlinico

Milan, , Italy

Site Status

Istituto Scientifico Universitario San Raffaele

Milan, , Italy

Site Status

Azienda Ospedaliera Universitaria Maggiore Della Carita di Novara

Novara, , Italy

Site Status

Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

Site Status

Azienda Ospedaliera di Perugia

Perugia, , Italy

Site Status

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Pesaro, , Italy

Site Status

Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto

Piacenza, , Italy

Site Status

Azienda Unita Sanitaria Locale di Ravenna

Ravenna, , Italy

Site Status

Arcispedale Santa Maria Nuova

Reggio Emilia, , Italy

Site Status

IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture

Rionero in Vulture, , Italy

Site Status

Universita degli Studi di Roma La Sapienza

Roma, , Italy

Site Status

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

Roma, , Italy

Site Status

Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

Site Status

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

Siena, , Italy

Site Status

Ospedale San Bortolo di Vicenza

Vicenza, , Italy

Site Status

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

Lisbon, , Portugal

Site Status

Fundació Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Site Status

Hospital General Universitario de Alicante

Alicante, , Spain

Site Status

Hospital Universitari Germans Trias i Pujol

Badalona, , Spain

Site Status

Hospital Universitari Mútua Terrassa

Barcelona, , Spain

Site Status

Hospital Universitario de Burgos

Burgos, , Spain

Site Status

Hospital De Cabuenes

Gijón, , Spain

Site Status

Hospital Universitario Donostia

Gipuzkoa, , Spain

Site Status

Institut Català d'Oncologia

L'Hospitalet de Llobregat, , Spain

Site Status

Hospital Universitario Severo Ochoa

Leganés, , Spain

Site Status

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Site Status

Hospital San Pedro de Alcantara

Madrid, , Spain

Site Status

Hospital Universitario Infanta Leonor

Madrid, , Spain

Site Status

Hospital Universitario Ramon Y Cajal

Madrid, , Spain

Site Status

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Site Status

Hospital Universitario Rey Juan Carlos

Móstoles, , Spain

Site Status

Hospital General Universitario Morales Meseguer

Murcia, , Spain

Site Status

Hospital Universitario Virgen de la Arrixaca

Murcia, , Spain

Site Status

Hospital Universitario Central de Asturias

Oviedo, , Spain

Site Status

Hospital Universitario Son Dureta

Palma de Mallorca, , Spain

Site Status

Clínica Universidad de Navarra

Pamplona, , Spain

Site Status

Hospital Universitario de Salamanca

Salamanca, , Spain

Site Status

Hospital Universitario de Canarias

Santa Cruz de Tenerife, , Spain

Site Status

Hospital Universitari Arnau De Vilanova (Huav)

Valencia, , Spain

Site Status

Hospital Clinico Universitario Lozano Blesa

Zaragoza, , Spain

Site Status

Hospital de Día Quirónsalud Zaragoza

Zaragoza, , Spain

Site Status

Karolinska Universitetssjukhuset

Stockholm, , Sweden

Site Status

Velindre NHS Trust

Cardiff, , United Kingdom

Site Status

St George's Healthcare NHS Trust

London, , United Kingdom

Site Status

South Tees Hospitals Nhs Foundation Trust

Middlesbrough, , United Kingdom

Site Status

Abertawe Bro Morgannwg University Health Board

Swansea, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria Belgium France Germany Greece Ireland Italy Portugal Spain Sweden United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EUPAS19618

Identifier Type: OTHER

Identifier Source: secondary_id

GS-EU-313-4172

Identifier Type: -

Identifier Source: org_study_id