Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL) Treated With Idelalisib and Rituximab in the Clinical Practice: a GIMEMA-ERIC Study (LLC178)

May 11, 2022 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto
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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy
        • Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
      • Ancona, Italy
        • Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona- Sod Clinica Ematologica
      • Ascoli Piceno, Italy
        • Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
      • Asti, Italy
        • Asl Di Asti, Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia
      • Brescia, Italy
        • Asst Degli Spedali Civili Di Brescia - Uo Ematologia
      • Cagliari, Italy
        • AO Brotzu, PO A.Businco - SC Ematologia e CTMO
      • Catania, Italy
        • Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania
      • Catanzaro, Italy
        • Ao Di Catanzaro "Pugliese-Ciaccio", Presidio Ospedaliero "Ciaccio - de Lellis" - Ematologia
      • Firenze, Italy
        • Aou Careggi - Firenze - Sod Ematologia
      • Meldola, Italy
        • I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica
      • Messina, Italy
        • Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - 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
        • ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
      • Milano, Italy
        • Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia
      • Modena, Italy
        • Aou Di Modena - Sc Ematologia
      • Napoli, Italy
        • Aou Federico Ii - Napoli - Uoc Ematologia
      • Palermo, Italy
        • Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
      • Palermo, Italy
        • Aou Policlinico P. Giaccone - Palermo - Uo Ematologia
      • Parma, Italy
        • Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo
      • Pavia, Italy
        • Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia
      • Piacenza, Italy
        • Asl Di Piacenza - Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
      • Potenza, Italy
        • Ao Regionale S. Carlo - Potenza - Sic Ematologia
      • Reggio Emilia, Italy
        • Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova - Irccs - Sc Ematologia
      • Rimini, Italy
        • Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
      • Rionero In Vulture, Italy
        • C.R.O.B. - I.R.C.C.S. - Rionero in Volture - Uoc Ematologia
      • Roma, Italy
        • Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
      • Roma, Italy
        • Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
      • Roma, Italy
        • Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali
      • Roma, Italy
        • AOU Policlinico Tor Vergata - UOC Trapianto Cellule Staminali
      • Roma, Italy
        • Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali
      • Siena, Italy
        • A.O.U. Senese - Policlinico "Le Scotte" - UOC EMATOLOGIA E TRAPIANTI
      • Torino, Italy
        • AOU Città della Salute e della Scienza, Ospedale S.Giovanni Battista Molinette - SC Ematologia
      • Treviso, Italy
        • Unità Operativa Di Ematologia - Presidio Ospedaliero Di Treviso - Azienda Ulss N.2 Marca Trevigiana
      • Udine, Italy
        • Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
      • Verona, Italy
        • Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
      • Vicenza, Italy
        • Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
    • Ferrara
      • Cona, Ferrara, Italy
        • AOU Arcispedale S.Anna - UOC Ematologia e fisiopatologia della coagulazione

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
All patients being observed during the study duration.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients responding to treatment
Time Frame: At 12 months from treatment start
Efficacy profile of idelalisib and rituximab
At 12 months from treatment start
Number of patients experiencing toxicities
Time Frame: At 12 months from treatment start
Safety profile of idelalisib and rituximab
At 12 months from treatment start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients alive
Time Frame: At 12 months from treatment start
Overall survival
At 12 months from treatment start
Number of patients alive without progression of the disease
Time Frame: At 12 months from treatment start
Progression-free-survival
At 12 months from treatment start
Number of patients achieving response
Time Frame: At 12 months from treatment start
Overall response rate
At 12 months from treatment start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Collaborators

ERIC Group

Investigators

  • Study Chair: Antonio Cuneo, Ematologia; Azienda Ospedaliera di Ferrara
  • Study Director: Gian Matteo Rigolin, Ematologia; Azienda Ospedaliera di Ferrara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 6, 2019

Primary Completion (ACTUAL)

October 28, 2020

Study Completion (ACTUAL)

October 28, 2020

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

May 22, 2018

First Posted (ACTUAL)

June 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 11, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LLC1718

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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