Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL) Treated With Idelalisib and Rituximab in the Clinical Practice: a GIMEMA-ERIC Study
NCT ID: NCT03545035
Last Updated: 2022-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
104 participants
OBSERVATIONAL
2019-02-06
2020-10-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Study group
All patients being observed during the study duration.
idelalisib and rituximab
patients with treatment-naïve chronic lymphocytic leukemia (CLL) with TP53 disruption (i.e. 17p- or TP53 mutations) or relapsed/refractory CLL who were treated with idelalisib and rituximab
Interventions
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idelalisib and rituximab
patients with treatment-naïve chronic lymphocytic leukemia (CLL) with TP53 disruption (i.e. 17p- or TP53 mutations) or relapsed/refractory CLL who were treated with idelalisib and rituximab
Eligibility Criteria
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Inclusion Criteria
* Treatment with idelalisib and rituximab started between the date of Country marketing authorization approval of idelalisib (EMA approval 18/09/2014) and 31/05/2017 given at European centres adhering to the GIMEMA group and the ERIC group.
* One of the two following conditions must be satisfied:
* Previously untreated CLL requiring therapy according to the NCI criteria (Hallek M et al, Blood 2008)\] with deletion 17p13 and/or TP53 mutation.
* Relapsed refractory CLL., i.e. patients who received at least one previous line of treatment using alkylating agents and/or purine analogues with or without monoclonal antibodies, or high dose steroids requiring therapy according to the NCI criteria (Hallek M et al, Blood 2008)
* Age ≥ 18 years.
* Signed written informed consent, if applicable, according to ICH/EU/GCP and national local law.
Exclusion Criteria
* Patients with:
* Transformation of CLL to aggressive lymphomas (Richter's Syndrome).
* HIV infection.
* Active and uncontrolled HCV and/or HBV infections or liver cirrhosis.
18 Years
ALL
No
Sponsors
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ERIC Group
UNKNOWN
Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
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Principal Investigators
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Antonio Cuneo
Role: STUDY_CHAIR
Ematologia; Azienda Ospedaliera di Ferrara
Gian Matteo Rigolin
Role: STUDY_DIRECTOR
Ematologia; Azienda Ospedaliera di Ferrara
Locations
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AOU Arcispedale S.Anna - UOC Ematologia e fisiopatologia della coagulazione
Cona, Ferrara, Italy
Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
Alessandria, , Italy
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona- Sod Clinica Ematologica
Ancona, , Italy
Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
Ascoli Piceno, , Italy
Asl Di Asti, Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia
Asti, , Italy
Asst Degli Spedali Civili Di Brescia - Uo Ematologia
Brescia, , Italy
AO Brotzu, PO A.Businco - SC Ematologia e CTMO
Cagliari, , Italy
Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania
Catania, , Italy
Ao Di Catanzaro "Pugliese-Ciaccio", Presidio Ospedaliero "Ciaccio - de Lellis" - Ematologia
Catanzaro, , Italy
Aou Careggi - Firenze - Sod Ematologia
Florence, , Italy
I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica
Meldola, , Italy
Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia
Messina, , Italy
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Milan, , Italy
Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia
Milan, , Italy
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
Milan, , Italy
Irccs Ospedale S. Raffaele - Milano - Unità Neoplasie Linfocitarie B
Milan, , Italy
Aou Di Modena - Sc Ematologia
Modena, , Italy
Aou Federico Ii - Napoli - Uoc Ematologia
Napoli, , Italy
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
Palermo, , Italy
Aou Policlinico P. Giaccone - Palermo - Uo Ematologia
Palermo, , Italy
Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo
Parma, , Italy
Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia
Pavia, , Italy
Asl Di Piacenza - Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
Piacenza, , Italy
Ao Regionale S. Carlo - Potenza - Sic Ematologia
Potenza, , Italy
Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova - Irccs - Sc Ematologia
Reggio Emilia, , Italy
Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
Rimini, , Italy
C.R.O.B. - I.R.C.C.S. - Rionero in Volture - Uoc Ematologia
Rionero in Vulture, , Italy
Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali
Roma, , Italy
AOU Policlinico Tor Vergata - UOC Trapianto cellule staminali
Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
Roma, , Italy
Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali
Roma, , Italy
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
Roma, , Italy
A.O.U. Senese - Policlinico "Le Scotte" - UOC EMATOLOGIA E TRAPIANTI
Siena, , Italy
AOU Città della Salute e della Scienza, Ospedale S.Giovanni Battista Molinette - SC Ematologia
Torino, , Italy
Unità Operativa Di Ematologia - Presidio Ospedaliero Di Treviso - Azienda Ulss N.2 Marca Trevigiana
Treviso, , Italy
Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
Udine, , Italy
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
Verona, , Italy
Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
Vicenza, , Italy
Countries
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Related Links
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GIMEMA Foundation website
Other Identifiers
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LLC1718
Identifier Type: -
Identifier Source: org_study_id
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