Follicular Non-Hodgkin's Lymphoma RefractoryZEUSNCT03568929
Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma
An observational study of Follicular Non-Hodgkin's Lymphoma Refractory, run by Gilead Sciences at 88 sites in 10 countries.
Trial summary
The primary objective of this study is to assess the overall safety profile of idelalisib monotherapy in patients with refractory follicular lymphoma (FL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Non-Hodgkin's Lymphoma Refractory
- What is being tested?
- Idelalisib
- Type of treatment
- Pill or oral medicine
- How many people
- 257 participants
- Where
- 88 sitesin 10 countries
- Study dates
- 25 May 2018to 29 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Individuals included in clinical trials on idelalisib within the timeframe of this study.
Trial locations and contacts
88 sites in 10 countries.
88 sites in 10 countries
Italy27 sites
Ospedali Riuniti di Ancona, Clinica Ematologica
Ancona, 60126
Ospedale Mazzoni
Ascoli Piceno
Azienda Ospedaliera Policlinico di Bari
Bari, 70124
Monsignor Raffaele Dimiccoli Hospital
Barletta, 70051
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, 25123
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi
Catania, 95122
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, 95124
Ospedale di Civitanova Marche
Civitanova Marche
Azienda Ospedaliero - Universitaria Careggi
Florence, 50134
Presidio Ospedaliero di Livorno
Livorno
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20100
Fondazione IRCCS Cà Grande Ospedale Maggiore Policlinico
Milan, 20122
Istituto Scientifico Universitario San Raffaele
Milan, 20132
Azienda Ospedaliera Universitaria Maggiore Della Carita di Novara
Novara, 28100
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Azienda Ospedaliera di Perugia
Perugia, 06129
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro, 61122
Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
Piacenza
Azienda Unita Sanitaria Locale di Ravenna
Ravenna, 48121
Arcispedale Santa Maria Nuova
Reggio Emilia, 42123
IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
Rionero in Vulture, 85028
Universita degli Studi di Roma La Sapienza
Roma, 00161
Istituti di Ricovero e Cura A Carattere Scientifico - Istituti Fisioterapici Ospitalieri
Roma
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013
Azienda Ospedaliera Universitaria Senese-L'ospedale Santa Maria alle Scotte
Siena, 53100
Ospedale San Bortolo di Vicenza
Vicenza
Spain25 sites
Hospital General Universitario de Alicante
Alicante, 3011
Hospital Universitari Germans Trias i Pujol
Badalona, 08916
Fundació Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 8025
Hospital Universitari Mútua Terrassa
Barcelona, 8221
Hospital Universitario de Burgos
Burgos, 09006
Hospital De Cabuenes
Gijón, 33394
Hospital Universitario Donostia
Gipuzkoa, 20014
Institut Català d'Oncologia
L'Hospitalet de Llobregat
Hospital Universitario Severo Ochoa
Leganés, 28911
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Hospital San Pedro de Alcantara
Madrid, 28009
Hospital Universitario Infanta Leonor
Madrid, 28031
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Hospital Universitario Rey Juan Carlos
Móstoles
Hospital General Universitario Morales Meseguer
Murcia, 30008
Hospital Universitario Virgen de la Arrixaca
Murcia, 30120
Hospital Universitario Central de Asturias
Oviedo, 33004
Hospital Universitario Son Dureta
Palma de Mallorca
Clínica Universidad de Navarra
Pamplona, 31008
Hospital Universitario de Salamanca
Salamanca, 37007
Hospital Universitario de Canarias
Santa Cruz de Tenerife, 38320
Hospital Universitari Arnau De Vilanova (Huav)
Valencia, 46015
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009
Hospital de Día Quirónsalud Zaragoza
Zaragoza, 50012
France17 sites
Centre Hospitalier Universitaire d'Amiens (CHU d'Amiens) - Hopital Nord
Amiens, 80054
Centre Hospitalier Bourg-en-Bresse Fleyriat
Bourg-en-Bresse
Centre Hospitalier de Cannes
Cannes, 06400
Hôpital Privé Sévigné
Cesson-Sévigné
Centre Hospitalier Chalon sur Saône William Morey
Chalon-sur-Saône, 71100
Centre Hospitalier Universitaire Estaing
Clermont-Ferrand, 63003
CHU de Dijon
Dijon, 2100
Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard
Grenoble
Clinique Victor Hugo
Le Mans, 72015
Centre Hospitalier Le Mans
Le Mans, 72037
Centre Hospitalier de Lens
Lens, 62300
Hôpital de la Conception
Marseille, 13005
Centre Hospitalier Régional d'Orléans
Orléans, 45650
Centre hospitalier de Perigueux
Pessac, 33604
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021
Hopital Bretonneau, Centre Henri Kaplan
Tours, Cedex 37044
Greece5 sites
University General Hospital of Alexandroupolis
Alexandroupoli, 68100
Athens Medical Center-Psychikon branch
Athens, 11525
Henry Dunant Hospital
Athens, 11526
University General Hospital of Patras
Pátrai, 265 04
AHEPA University General Hospital of Thessaloniki
Thessaloniki, 54636
Germany4 sites
Klinikum Frankfurt Hochst
Frankfurt, 65929
Universitätsmedizin Göttingen
Göttingen, 37075
Klinikum Südstadt Rostock
Rostock
Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede
Westerstede, 26655
United Kingdom4 sites
Velindre NHS Trust
Cardiff
St George's Healthcare NHS Trust
London, SW17 0QT
South Tees Hospitals Nhs Foundation Trust
Middlesbrough, TS4 3BW
Abertawe Bro Morgannwg University Health Board
Swansea, SA2 8QA
Ireland3 sites
Saint James's Hospital
Dublin, 8
Mater Misericordiae University Hospital
Dublin, Dublin 7
Midland Regional Hospital - Mullingar
Mullingar
Portugal1 site
Instituto Português de Oncologia Francisco Gentil, Centro Regional de Lisboa SA
Lisbon, 1090-023
About this study
Official title: 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).
- Being tested
- Idelalisib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IdelalisibDrug
Also called Zydelig®
Tablets administered according to the product information and treatment guidelines in routine clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Idelalisib | Participants who have been or are currently being treated with 100 or 150 mg of idelalisib Receives: Drug: Idelalisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
OS is defined as the interval from the date of initiation of idelalisib to death from any cause.
Measured: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start25 May 2018
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular Non-Hodgkin's Lymphoma RefractoryStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568929
- Sponsor's protocol ID
- GS-EU-313-4172
- Other IDs
- EUPAS19618
- Acronym
- ZEUS
- Status last verified
- Nov 2021
- First submitted
- 14 Jun 2018
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study to Assess the Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma (FL)
- ClinicalTrials.gov ID
- NCT03568929
- Acronym / sponsor ID
- ZEUS / GS-EU-313-4172
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 25 May 2018 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the overall safety profile of idelalisib monotherapy in patients with refractory follicular lymphoma (FL).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idelalisib | – | Drug: IdelalisibParticipants who have been or are currently being treated with 100 or 150 mg of idelalisib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Individuals included in clinical trials on idelalisib within the timeframe of this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IdelalisibAlso: Zydelig®Tablets administered according to the product information and treatment guidelines in routine clinical practice | Drug | Idelalisib |
Primary outcome
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)
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
88 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Follicular Non-Hodgkin's Lymphoma Refractory, run by Gilead Sciences at 88 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 88 sites in Italy, Spain, France, Greece, Germany and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.