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
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

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

External Links

•   GIMEMA Foundation website