Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma (ZEUS)

November 16, 2021 updated by: Gilead Sciences

Non-interventional Study to Assess the Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma (FL)

The primary objective of this study is to assess the overall safety profile of idelalisib monotherapy in patients with refractory follicular lymphoma (FL).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

257

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2060
        • Ziekenhuis Netwerk Antwerpen Stuivenberg Hospital
  • France
      • Amiens Cedex 1, France, 80054
        • Centre Hospitalier Universitaire d'Amiens (CHU d'Amiens) - Hopital Nord
      • Bourg-en-Bresse, France
        • Centre Hospitalier Bourg-en-Bresse Fleyriat
      • Cannes, France, 06400
        • Centre Hospitalier de Cannes
      • Cesson-Sevigne, France
        • Hôpital Privé Sévigné
      • Chalon-Sur-Saone, France, 71100
        • Centre Hospitalier Chalon Sur Saône William Morey
      • Clermont-Ferrand, France, 63003
        • Centre Hospitalier Universitaire Estaing
      • Dijon, France, 2100
        • CHU de Dijon
      • Grenoble, France
        • Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard
      • Le Mans, France, 72037
        • Centre Hospitalier Le Mans
      • Le Mans Cedex 2, France, 72015
        • Clinique Victor Hugo
      • Lens, France, 62300
        • Centre Hospitalier de LENS
      • Marseille, France, 13005
        • Hôpital de la Conception
      • Orléans, France, 45650
        • Centre Hospitalier Regional D'Orleans
      • Pessac, France, 33604
        • Centre Hospitalier de Perigueux
      • Pierre Bénite Cedex, France, 69495
        • Centre Hospitalier Lyon Sud
      • Poitiers Cedex, France, 86021
        • Centre Hospitalier Universitaire de Poitiers
      • Tours, France, Cedex 37044
        • Hopital Bretonneau, Centre Henri Kaplan
  • Germany
      • Frankfurt, Germany, 65929
        • Klinikum Frankfurt Höchst
      • Göttingen, Germany, 37075
        • Universitatsmedizin Gottingen
      • Rostock, Germany
        • Klinikum Südstadt Rostock
      • Westerstede, Germany, 26655
        • Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede
  • Greece
      • Alexandroupolis, Greece, 68100
        • University General Hospital of Alexandroupolis
      • Athens, Greece, 11526
        • Henry Dunant hospital
      • Athens, Greece, 11525
        • Athens Medical Center-Psychikon branch
      • Patra, Greece, 265 04
        • University General Hospital of Patras
      • Thessaloniki, Greece, 54636
        • Ahepa University General Hospital of Thessaloniki
  • Ireland
      • Dublin, Ireland, Dublin 7
        • Mater Misericordiae University Hospital
      • Dublin, Ireland, 8
        • Saint James's Hospital
      • Mullingar, Ireland
        • Midland Regional Hospital - Mullingar
  • Italy
      • Ancona, Italy, 60126
        • Ospedali Riuniti di Ancona, Clinica Ematologica
      • Ascoli Piceno, Italy
        • Ospedale Mazzoni
      • Bari, Italy, 70124
        • Azienda Ospedaliera Policlinico di Bari
      • Barletta, Italy, 70051
        • Monsignor Raffaele Dimiccoli Hospital
      • Brescia, Italy, 25123
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
      • Catania, Italy, 95122
        • Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
      • Catania, Italy, 95124
        • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
      • Civitanova Marche, Italy
        • Ospedale di Civitanova Marche
      • Florence, Italy, 50134
        • Azienda Ospedaliero - Universitaria Careggi
      • Livorno, Italy
        • Presidio Ospedaliero di Livorno
      • Meldola, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Milano, Italy, 20132
        • Istituto scientifico universitario San Raffaele
      • Milano, Italy, 20100
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milano, Italy, 20122
        • Fondazione IRCCS Cà Grande Ospedale Maggiore Policlinico
      • Novara, Italy, 28100
        • Azienda Ospedaliera Universitaria Maggiore della Carita di Novara
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo
      • Perugia, Italy, 06129
        • Azienda Ospedaliera di Perugia
      • Pesaro, Italy, 61122
        • Azienda Ospedaliera Ospedali Riuniti Marche Nord
      • Piacenza, Italy
        • Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
      • Ravenna, Italy, 48121
        • Azienda Unita Sanitaria Locale di Ravenna
      • Reggio Emilia, Italy, 42123
        • Arcispedale Santa Maria Nuova
      • Rionero in Vulture, Italy, 85028
        • IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
      • Roma, Italy, 00161
        • Università degli Studi di Roma La Sapienza
      • Roma, Italy
        • Istituti di Ricovero e Cura A Carattere Scientifico - Istituti Fisioterapici Ospitalieri
      • San Giovanni Rotondo, Italy, 71013
        • Ospedale Casa Sollievo della Sofferenza
      • Siena, Italy, 53100
        • Azienda Ospedaliera Universitaria Senese-L'ospedale Santa Maria alle Scotte
      • Vicenza, Italy
        • Ospedale San Bortolo di Vicenza
  • Portugal
      • Lisbon, Portugal, 1090-023
        • Instituto Português de Oncologia Francisco Gentil, Centro Regional de Lisboa SA
  • Spain
      • Alicante, Spain, 3011
        • Hospital General Universitario de Alicante
      • Badalona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain, 8221
        • Hospital Universitari Mutua Terrassa
      • Burgos, Spain, 09006
        • Hospital Universitario de Burgos
      • Gijon, Spain, 33394
        • Hospital de Cabueñes
      • Gipuzkoa, Spain, 20014
        • Hospital Universitario Donostia
      • L'Hospitalet de LLobregat, Spain
        • Institut Catala d'Oncologia
      • Leganés, Spain, 28911
        • Hospital Universitario Severo Ochoa
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor
      • Madrid, Spain, 28009
        • Hospital San Pedro de Alcántara
      • Murcia, Spain, 30120
        • Hospital Universitario Virgen de la Arrixaca
      • Murcia, Spain, 30008
        • Hospital General Universitario Morales Meseguer
      • Móstoles, Spain
        • Hospital Universitario Rey Juan carlos
      • Oviedo, Spain, 33004
        • Hospital Universitario Central de Asturias
      • Palma de Mallorca, Spain
        • Hospital Universitario Son Dureta
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • Santa Cruz de Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
      • Valencia, Spain, 46015
        • Hospital Universitari Arnau De Vilanova (Huav)
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa
      • Zaragoza, Spain, 50012
        • Hospital de Día Quirónsalud Zaragoza
    • Cataluña
      • Barcelona, Cataluña, Spain, 8025
        • Fundació Hospital de la Santa Creu i Sant Pau
  • Sweden
      • Stockholm, Sweden, 141 86
        • Karolinska Universitetssjukhuset
  • United Kingdom
      • Cardiff, United Kingdom
        • Velindre NHS Trust
      • London, United Kingdom, SW17 0QT
        • St George's Healthcare NHS Trust
      • Middlesbrough, United Kingdom, TS4 3BW
        • South Tees Hospitals NHS Foundation Trust
      • Swansea, United Kingdom, SA2 8QA
        • Abertawe Bro Morgannwg University Health Board

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Idelalisib
Participants who have been or are currently being treated with 100 or 150 mg of idelalisib
Drug: Idelalisib
Tablets administered according to the product information and treatment guidelines in routine clinical practice
Other Names:
  • Zydelig®

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)
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

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 25, 2018

Primary Completion (ACTUAL)

October 29, 2021

Study Completion (ACTUAL)

October 29, 2021

Study Registration Dates

First Submitted

June 14, 2018

First Submitted That Met QC Criteria

June 14, 2018

First Posted (ACTUAL)

June 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-EU-313-4172
  • EUPAS19618 (OTHER: ENCePP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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