Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL) Treated With Idelalisib and Rituximab in the Clinical Practice: a GIMEMA-ERIC Study
LLC178
1 other identifier
observational
104
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2019
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2018
CompletedFirst Posted
Study publicly available on registry
June 4, 2018
CompletedStudy Start
First participant enrolled
February 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2020
CompletedMay 12, 2022
May 1, 2022
1.7 years
May 22, 2018
May 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of patients responding to treatment
Efficacy profile of idelalisib and rituximab
At 12 months from treatment start
Number of patients experiencing toxicities
Safety profile of idelalisib and rituximab
At 12 months from treatment start
Secondary Outcomes (3)
Number of patients alive
At 12 months from treatment start
Number of patients alive without progression of the disease
At 12 months from treatment start
Number of patients achieving response
At 12 months from treatment start
Study Arms (1)
Study group
All patients being observed during the study duration.
Interventions
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
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gruppo Italiano Malattie EMatologiche dell'Adultolead
- ERIC Groupcollaborator
Study Sites (38)
AOU Arcispedale S.Anna - UOC Ematologia e fisiopatologia della coagulazione
Cona, Ferrara, 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 Careggi - Firenze - Sod Ematologia
Florence, 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
Milan, Italy
Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia
Milan, Italy
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
Milan, Italy
Irccs Ospedale S. Raffaele - Milano - Unità Neoplasie Linfocitarie B
Milan, 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, Italy
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Antonio Cuneo
Ematologia; Azienda Ospedaliera di Ferrara
- STUDY DIRECTOR
Gian Matteo Rigolin
Ematologia; Azienda Ospedaliera di Ferrara
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2018
First Posted
June 4, 2018
Study Start
February 6, 2019
Primary Completion
October 28, 2020
Study Completion
October 28, 2020
Last Updated
May 12, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share