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

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)

Overall Status

Completed

CT.gov ID

NCT03545035

Collaborator

ERIC Group (Other)

104

Enrollment

Locations

20.7

Actual Duration (Months)

2.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia	Drug: idelalisib and rituximab

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 Design

Study Type:

Observational

Actual Enrollment :

104 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Feb 6, 2019

Actual Primary Completion Date :

Oct 28, 2020

Actual Study Completion Date :

Oct 28, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Number of patients responding to treatment [At 12 months from treatment start]
Efficacy profile of idelalisib and rituximab
Number of patients experiencing toxicities [At 12 months from treatment start]
Safety profile of idelalisib and rituximab

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	AOU Arcispedale S.Anna - UOC Ematologia e fisiopatologia della coagulazione	Cona	Ferrara	Italy
2	Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia	Alessandria		Italy
3	Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona- Sod Clinica Ematologica	Ancona		Italy
4	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
5	Asl Di Asti, Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia	Asti		Italy
6	Asst Degli Spedali Civili Di Brescia - Uo Ematologia	Brescia		Italy
7	AO Brotzu, PO A.Businco - SC Ematologia e CTMO	Cagliari		Italy
8	Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania	Catania		Italy
9	Ao Di Catanzaro "Pugliese-Ciaccio", Presidio Ospedaliero "Ciaccio - de Lellis" - Ematologia	Catanzaro		Italy
10	Aou Careggi - Firenze - Sod Ematologia	Firenze		Italy
11	I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica	Meldola		Italy
12	Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia	Messina		Italy
13	ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia	Milano		Italy
14	Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia	Milano		Italy
15	Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora	Milano		Italy
16	Irccs Ospedale S. Raffaele - Milano - Unità Neoplasie Linfocitarie B	Milano		Italy
17	Aou Di Modena - Sc Ematologia	Modena		Italy
18	Aou Federico Ii - Napoli - Uoc Ematologia	Napoli		Italy
19	Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo	Palermo		Italy
20	Aou Policlinico P. Giaccone - Palermo - Uo Ematologia	Palermo		Italy
21	Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo	Parma		Italy
22	Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia	Pavia		Italy
23	Asl Di Piacenza - Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti	Piacenza		Italy
24	Ao Regionale S. Carlo - Potenza - Sic Ematologia	Potenza		Italy
25	Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova - Irccs - Sc Ematologia	Reggio Emilia		Italy
26	Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia	Rimini		Italy
27	C.R.O.B. - I.R.C.C.S. - Rionero in Volture - Uoc Ematologia	Rionero In Vulture		Italy
28	Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali	Roma		Italy
29	AOU Policlinico Tor Vergata - UOC Trapianto cellule staminali	Roma		Italy
30	Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica	Roma		Italy
31	Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali	Roma		Italy
32	Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia	Roma		Italy
33	A.O.U. Senese - Policlinico "Le Scotte" - UOC EMATOLOGIA E TRAPIANTI	Siena		Italy
34	AOU Città della Salute e della Scienza, Ospedale S.Giovanni Battista Molinette - SC Ematologia	Torino		Italy
35	Unità Operativa Di Ematologia - Presidio Ospedaliero Di Treviso - Azienda Ulss N.2 Marca Trevigiana	Treviso		Italy
36	Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica	Udine		Italy
37	Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia	Verona		Italy
38	Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia	Vicenza		Italy