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

Completed

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Drug: idelalisib and rituximab

• Registration Number: NCT03545035
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Study Timeline

• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-05-22
• Study First Posted: 2018-06-04
• Study Start: 2019-02-06
• Primary Completion: 2020-10-28
• Study Completion: 2020-10-28
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-11
• Last Update Posted: 2022-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	idelalisib and rituximab	All patients being observed during the study duration.

Primary Outcome Measures

Name	Time	Method
Number of patients experiencing toxicities	At 12 months from treatment start	Safety profile of idelalisib and rituximab
Number of patients responding to treatment	At 12 months from treatment start	Efficacy profile of idelalisib and rituximab

Secondary Outcome Measures

Name	Time	Method
Number of patients alive	At 12 months from treatment start	Overall survival
Number of patients achieving response	At 12 months from treatment start	Overall response rate
Number of patients alive without progression of the disease	At 12 months from treatment start	Progression-free-survival

Trial Locations

Locations (38)

I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica; 🇮🇹 Meldola, Italy

Aou Di Modena - Sc Ematologia; 🇮🇹 Modena, Italy

Aou Federico Ii - Napoli - Uoc Ematologia; 🇮🇹 Napoli, Italy

Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona- Sod Clinica Ematologica; 🇮🇹 Ancona, Italy

Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia; 🇮🇹 Messina, Italy

Irccs Ospedale S. Raffaele - Milano - Unità Neoplasie Linfocitarie B; 🇮🇹 Milano, Italy

Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia; 🇮🇹 Pavia, Italy

Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia; 🇮🇹 Vicenza, Italy

Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia; 🇮🇹 Alessandria, 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; 🇮🇹 Firenze, 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

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

Asl Di Piacenza - Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti; 🇮🇹 Piacenza, Italy

Ao Regionale S. Carlo - Potenza - Sic Ematologia; 🇮🇹 Potenza, 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

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

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

AOU Arcispedale S.Anna - UOC Ematologia e fisiopatologia della coagulazione; 🇮🇹 Cona, Ferrara, Italy