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JOURNAL ONKOLOGIE – STUDIE
ZEUS

Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma

Rekrutierend

NCT-Nummer:
NCT03568929

Studienbeginn:
Mai 2018

Letztes Update:
08.04.2021

Wirkstoff:
Idelalisib

Indikation (Clinical Trials):
Lymphoma, Lymphoma, Follicular

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Gilead Sciences

Collaborator:
-

Studienleiter

Gilead Study Director
Study Director
Gilead Sciences

Kontakt

Gilead Clinical Study Information Center
Kontakt:
Phone: 1-833-445-3230 (GILEAD-0)
E-Mail: GileadClinicalTrials@gilead.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 94)

Klinikum Saint Marien Amberg
92224 Amberg
(Bayern)
GermanyZurückgezogen» Google-Maps
Klinikum Frankfurt Hochst
65929 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
Brustzentrum der Universitätsmedizin Göttingen
Robert-Koch-Straße 40
37075 Göttingen
DeutschlandRekrutierend» Google-Maps
Pankreaskarzinomzentrum am Klinikum Südstadt Rostock
Südring 81
18059 Rostock
DeutschlandRekrutierend» Google-Maps
Caritas Klinikum Saarbrücken
D-66113 Saarbrücken
(Saarland)
GermanyZurückgezogen» Google-Maps
Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede
26655 Westerstede
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Ziekenhuis Netwerk Antwerpen Stuivenberg Hospital
2060 Antwerpen
BelgiumRekrutierend» Google-Maps
Centre Hospitalier Universitaire d'Amiens (CHU d'Amiens) - Hopital Nord
80054 Amiens Cedex 1
FranceRekrutierend» Google-Maps
Centre Hospitalier Bourg-en-Bresse Fleyriat
Bourg-en-Bresse
FranceRekrutierend» Google-Maps
Centre Hospitalier Chalon sur Saône William Morey
71100 Chalon-Sur-Saone
FranceRekrutierend» Google-Maps
Centre Hospitalier Universitaire Estaing
63003 Clermont-Ferrand
FranceRekrutierend» Google-Maps
Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard
Grenoble
FranceRekrutierend» Google-Maps
Centre Hospitalier Régional d'Orléans
45650 Orléans
FranceRekrutierend» Google-Maps
Centre hospitalier de Perigueux
33604 Pessac
FranceAbgeschlossen» Google-Maps
Centre Hospitalier Lyon Sud
69495 Pierre Bénite Cedex
FranceRekrutierend» Google-Maps
Centre Hospitalier Universitaire de Poitiers
86021 Poitiers Cedex
FranceRekrutierend» Google-Maps
Hopital Bretonneau, Centre Henri Kaplan
Cedex 37044 Tours
FranceRekrutierend» Google-Maps
University General Hospital of Alexandroupolis
68100 Alexandroupolis
GreeceRekrutierend» Google-Maps
Athens Medical Center-Psychikon branch
11525 Athens
GreeceRekrutierend» Google-Maps
University General Hospital of Patras
265 04 Patra
GreeceRekrutierend» Google-Maps
Metropolitan Hospital, Department of Hepatology
18547 Piraeus
GreeceZurückgezogen» Google-Maps
AHEPA University General Hospital of Thessaloniki
54636 Thessaloniki
GreeceRekrutierend» Google-Maps
Theagenio Anticancer Hospital of Thessaloniki
Thessaloniki
GreeceZurückgezogen» Google-Maps
Mater Misericordiae University Hospital
Dublin 7 Dublin
IrelandRekrutierend» Google-Maps
Midland Regional Hospital - Mullingar
Mullingar
IrelandRekrutierend» Google-Maps
Ospedali Riuniti di Ancona, Clinica Ematologica
60126 Ancona
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Policlinico di Bari
70124 Bari
ItalyRekrutierend» Google-Maps
Monsignor Raffaele Dimiccoli Hospital
70051 Barletta
ItalyRekrutierend» Google-Maps
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
25123 Brescia
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi
95122 Catania
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
95124 Catania
ItalyRekrutierend» Google-Maps
Ospedale di Civitanova Marche
Civitanova Marche
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero - Universitaria Careggi
50134 Florence
ItalyRekrutierend» Google-Maps
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
47014 Meldola
ItalyRekrutierend» Google-Maps
Fondazione IRCCS Istituto Nazionale dei Tumori
20100 Milano
ItalyRekrutierend» Google-Maps
Fondazione IRCCS Cà Grande Ospedale Maggiore Policlinico
20122 Milano
ItalyRekrutierend» Google-Maps
Istituto Scientifico Universitario San Raffaele
20132 Milano
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Maggiore Della Carita di Novara
28100 Novara
ItalyRekrutierend» Google-Maps
Fondazione IRCCS Policlinico San Matteo
27100 Pavia
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera di Perugia
06129 Perugia
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro
ItalyRekrutierend» Google-Maps
Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
Piacenza
ItalyRekrutierend» Google-Maps
Azienda Unita Sanitaria Locale di Ravenna
48121 Ravenna
ItalyRekrutierend» Google-Maps
Arcispedale Santa Maria Nuova
42123 Reggio Emilia
ItalyRekrutierend» Google-Maps
IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
85028 Rionero in Vulture
ItalyRekrutierend» Google-Maps
Universita degli Studi di Roma La Sapienza
00161 Roma
ItalyRekrutierend» Google-Maps
Istituti di Ricovero e Cura A Carattere Scientifico - Istituti Fisioterapici Ospitalieri
Roma
ItalyRekrutierend» Google-Maps
Ospedale Casa Sollievo della Sofferenza
71013 San Giovanni Rotondo
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Senese-L'ospedale Santa Maria alle Scotte
53100 Siena
ItalyRekrutierend» Google-Maps
Instituto Português de Oncologia Francisco Gentil, Centro Regional de Lisboa SA
1090-023 Lisbon
PortugalRekrutierend» Google-Maps
Fundació Hospital de la Santa Creu i Sant Pau
8025 Barcelona
SpainRekrutierend» Google-Maps
Hospital General Universitario de Alicante
3011 Alicante
SpainRekrutierend» Google-Maps
Hospital Universitari Germans Trias i Pujol
08916 Badalona
SpainRekrutierend» Google-Maps
Hospital Universitari Mútua Terrassa
8221 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario de Burgos
09006 Burgos
SpainRekrutierend» Google-Maps
Hospital Universitario Donostia
20014 Gipuzkoa
SpainRekrutierend» Google-Maps
Institut Català d'Oncologia
L'Hospitalet de LLobregat
SpainRekrutierend» Google-Maps
Hospital Universitario Severo Ochoa
28911 Leganés
SpainRekrutierend» Google-Maps
Hospital General Universitario Gregorio Maranon
28007 Madrid
SpainRekrutierend» Google-Maps
Hospital San Pedro de Alcantara
28009 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Infanta Leonor
28031 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Ramon Y Cajal, Carretera de Colmenar Viejo Km 9.100
28034 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Ramon Y Cajal, Servicio Hematologia HURyC. Crtra. De Colmenar Viejo, Km 9.100
28034 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Fundacion Jimenez Diaz
28040 Madrid
SpainRekrutierend» Google-Maps
Hospital General Universitario Morales Meseguer
30008 Murcia
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen de la Arrixaca
30120 Murcia
SpainRekrutierend» Google-Maps
Hospital Universitario Rey Juan Carlos
Móstoles
SpainAbgeschlossen» Google-Maps
Hospital Universitario Central de Asturias
33004 Oviedo
SpainRekrutierend» Google-Maps
Hospital Universitario Son Dureta
Palma de Mallorca
SpainRekrutierend» Google-Maps
Clínica Universidad de Navarra
31008 Pamplona
SpainRekrutierend» Google-Maps
Hospital Universitario de Salamanca
37007 Salamanca
SpainRekrutierend» Google-Maps
Hospital Universitario de Canarias
38320 Santa Cruz de Tenerife
SpainRekrutierend» Google-Maps
Hospital Universitari Arnau De Vilanova (Huav)
46015 Valencia
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario Lozano Blesa
50009 Zaragoza
SpainRekrutierend» Google-Maps
Hospital de Día Quirónsalud Zaragoza
50012 Zaragoza
SpainAktiv, nicht rekrutierend» Google-Maps
Karolinska Universitetssjukhuset
141 86 Stockholm
SwedenRekrutierend» Google-Maps
St George's Healthcare NHS Trust
SW17 0QT London
United KingdomRekrutierend» Google-Maps
South Tees Hospitals Nhs Foundation Trust
TS4 3BW Middlesbrough
United KingdomAktiv, nicht rekrutierend» Google-Maps
Abertawe Bro Morgannwg University Health Board
SA2 8QA Swansea
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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).

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

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



Secondary outcome:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Geprüfte Regime

  • Idelalisib (Zydelig®):
    Tablets administered according to the product information and treatment guidelines in routine clinical practice

Quelle: ClinicalTrials.gov


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