Clinical trial NCT03545035: Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL) Treated With Idelalisib and Rituximab in the Clinical Practice: a GIMEMA-ERIC Study
Official title: Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL) Treated With Idelalisib and Rituximab in the Clinical Practice: a GIMEMA-ERIC Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia
Idelalisib
Rituximab
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
Collaborators: name: ERIC Group
First posted: 2018-06-04
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This cohort study will recruit 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 between 01/07/2014 and 31/05/2017 at European centres adhering to the GIMEMA group and the ERIC group.

Brief summary: The present study aims at obtaining more in-depth information on how patients with chronic lymphocytic leukemia treated with idelalisib and rituximab react to treatment.

Detailed description: This cohort study will recruit 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 between 01/07/2014 and 31/05/2017 at European centres adhering to the GIMEMA group and the ERIC group.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of CLL / Small Lymphocytic Lymphoma (CLL/SLL) according to the World Health Organisation (WHO) classification 2008.
* 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 CLL treated with idelalisib within interventional clinical trials or outside the approved indication.
* Patients with:

  * Transformation of CLL to aggressive lymphomas (Richter's Syndrome).
  * HIV infection.
  * Active and uncontrolled HCV and/or HBV infections or liver cirrhosis.

Primary outcomes:
measure: Number of patients responding to treatment
timeFrame: At 12 months from treatment start
measure: Number of patients experiencing toxicities
timeFrame: At 12 months from treatment start
Secondary outcomes:
measure: Number of patients alive
timeFrame: At 12 months from treatment start
measure: Number of patients alive without progression of the disease
timeFrame: At 12 months from treatment start
measure: Number of patients achieving response
timeFrame: At 12 months from treatment start
Other outcomes:
Locations:
city: Cona
country: Italy
facility: AOU Arcispedale S.Anna - UOC Ematologia e fisiopatologia della coagulazione
state: Ferrara
city: Alessandria
country: Italy
facility: Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
city: Ancona
country: Italy
facility: Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona- Sod Clinica Ematologica
city: Ascoli Piceno
country: Italy
facility: Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
city: Asti
country: Italy
facility: Asl Di Asti, Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia
city: Brescia
country: Italy
facility: Asst Degli Spedali Civili Di Brescia - Uo Ematologia
city: Cagliari
country: Italy
facility: AO Brotzu, PO A.Businco - SC Ematologia e CTMO
city: Catania
country: Italy
facility: Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania
city: Catanzaro
country: Italy
facility: Ao Di Catanzaro "Pugliese-Ciaccio", Presidio Ospedaliero "Ciaccio - de Lellis" - Ematologia
city: Firenze
country: Italy
facility: Aou Careggi - Firenze - Sod Ematologia
city: Meldola
country: Italy
facility: I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica
city: Messina
country: Italy
facility: Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
city: Milano
country: Italy
facility: Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia
city: Milano
country: Italy
facility: Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
city: Milano
country: Italy
facility: Irccs Ospedale S. Raffaele - Milano - Unità Neoplasie Linfocitarie B
city: Modena
country: Italy
facility: Aou Di Modena - Sc Ematologia
city: Napoli
country: Italy
facility: Aou Federico Ii - Napoli - Uoc Ematologia
city: Palermo
country: Italy
facility: Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
city: Palermo
country: Italy
facility: Aou Policlinico P. Giaccone - Palermo - Uo Ematologia
city: Parma
country: Italy
facility: Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo
city: Pavia
country: Italy
facility: Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia
city: Piacenza
country: Italy
facility: Asl Di Piacenza - Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
city: Potenza
country: Italy
facility: Ao Regionale S. Carlo - Potenza - Sic Ematologia
city: Reggio Emilia
country: Italy
facility: Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova - Irccs - Sc Ematologia
city: Rimini
country: Italy
facility: Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
city: Rionero In Vulture
country: Italy
facility: C.R.O.B. - I.R.C.C.S. - Rionero in Volture - Uoc Ematologia
city: Roma
country: Italy
facility: Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali
city: Roma
country: Italy
facility: AOU Policlinico Tor Vergata - UOC Trapianto cellule staminali
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali
city: Roma
country: Italy
facility: Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
city: Siena
country: Italy
facility: A.O.U. Senese - Policlinico "Le Scotte" - UOC EMATOLOGIA E TRAPIANTI
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza, Ospedale S.Giovanni Battista Molinette - SC Ematologia
city: Treviso
country: Italy
facility: Unità Operativa Di Ematologia - Presidio Ospedaliero Di Treviso - Azienda Ulss N.2 Marca Trevigiana
city: Udine
country: Italy
facility: Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
city: Verona
country: Italy
facility: Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
city: Vicenza
country: Italy
facility: Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
Study officials:
affiliation: Ematologia; Azienda Ospedaliera di Ferrara
name: Antonio Cuneo
role: STUDY_CHAIR
affiliation: Ematologia; Azienda Ospedaliera di Ferrara
name: Gian Matteo Rigolin
role: STUDY_DIRECTOR
References: