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NCT03545035 Clinical Trial

Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL) Treated With Idelalisib and Rituximab in the Clinical Practice: a GIMEMA-ERIC Study

Chronic Lymphocytic Leukemia Clinical Trial

— LLC178  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03545035
Other study ID # LLC1718
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 6, 2019
Est. completion date October 28, 2020

Study information
Verified date May 2022
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 104
Est. completion date October 28, 2020
Est. primary completion date October 28, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
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 Arcispedale S.Anna - UOC Ematologia e fisiopatologia della coagulazione Cona Ferrara
Italy Aou Careggi - Firenze - Sod Ematologia Firenze
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 Milano
Italy Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia Milano
Italy Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora Milano
Italy Irccs Ospedale S. Raffaele - Milano - Unità Neoplasie Linfocitarie B Milano
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

Sponsors (2)
Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto ERIC Group

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients responding to treatment Efficacy profile of idelalisib and rituximab At 12 months from treatment start
Primary Number of patients experiencing toxicities Safety profile of idelalisib and rituximab At 12 months from treatment start
Secondary Number of patients alive Overall survival At 12 months from treatment start
Secondary Number of patients alive without progression of the disease Progression-free-survival At 12 months from treatment start
Secondary Number of patients achieving response Overall response rate At 12 months from treatment start
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