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NCT02491398 Clinical Trial

Efficacy and Safety of Bendamustine Plus Rituximab in Chronic Lympocytic Leukemia

Chronic Lymphocytic Leukemia Clinical Trial

— LLC1315  

Official title:
Observational Study to Assess the Efficacy and Safety of Bendamustine Plus Rituximab in Patients Affected by Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02491398
Other study ID # LLC1315
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2016
Est. completion date January 2017

Study information
Verified date October 2020
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is intended for Chronic Lymphocytic Leukemia patients who have already undergone a first or second treatment with drugs named bendamustine and rituximab. It will observe the results of this treatment and evaluate its efficacy and side effects.

Description:

This cohort study will recruit chronic lymphocytic leukemia (CLL) patients who were treated with first and second-line Bendamustine plus Rituximab (BR) from January 2008 to December 2014 from European centres adhering to the GIMEMA group and the ERIC group, and aims at observing the progression-free survival in CLL patients.

Recruitment information / eligibility
Status Completed
Enrollment 494
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of CLL / Small Lymphocytic Lymphoma (CLL/) according to the World Health Organisation (WHO) classification 2008.

- Patients who were treated with first and second-line Bendamustine plus Rituximab (BR) from January 2008 to December 2014 from European centres adhering to the GIMEMA group and the ERIC group.

- Previously untreated CLL patients requiring therapy according to the NCI criteria (Hallek M et al, Blood 2008 - Appendix G) and treated with at least one cycle of BR as first-line treatment.

- CLL patients that received one previous line of treatment using alkylating agents and/or purine analogues with or without monoclonal antibodies, requiring second-line therapy according to the NCI criteria (Hallek M et al, Blood 2008 - Appendix G) and treated with at least one cycle of bendamustine and rituximab.

- Age = 18 years old.

- Signed written informed consent according to ICH/EU/GCP and national local law.

Exclusion Criteria:

- Patients who have received 2 or more lines of prior therapy.

- Patients with:

Transformation of CLL into aggressive lymphomas (Richter's Syndrome). HIV infection. Active and uncontrolled HCV and/or HBV infections or liver cirrhosis.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bendamustine + Rituximab

Locations
Country Name City State
Italy Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI Ancona
Italy U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno Ascoli Piceno
Italy S.O.C. di Medicina Interna B - Ospedale - Cardinal Massaia di Asti Asti
Italy Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi Bologna
Italy Comprensorio Sanitario di Bolzano - Azienda Sanitaria dell'Alto Adige - Ematologia e Centro TMO - Ospedale S.Maurizio Bolzano
Italy ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO Cagliari
Italy Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto" Catania
Italy Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia Catanzaro
Italy Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi Cona
Italy U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza Cosenza
Italy S.C. Ematologia ASO S. Croce e Carle Cuneo
Italy Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna Ferrara
Italy Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano Firenze
Italy UOC di Ematologia con trapianto Ospedale S. Maria Gorett Latina
Italy Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST Meldola
Italy Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte" P.O. Papardo Messina
Italy Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano Milano
Italy U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele Milano
Italy Unità Trapianto di Midollo Ist. Nazionale Tumori Milano
Italy UO Ematologia - AOU Policlinico di Modena Modena
Italy S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro Novara
Italy Università degli Studi di Padova - Ematologia ed Immunologia Clinica Padova
Italy U.O. di Oncoematologia di Nocera Inferiore-plesso ospedaliero "A. Tortora" di Pagani del DEA Nocera-Pagani Pagani
Italy U.O. di Ematologia con trapianto - Centro di Riferimento Regionale per le coagulopatie rare nel bambino e nell'adulto Dipart. Biomedico di Medicina Interna - A.U. Policlinico "Paolo Giaccone" Palermo
Italy Cattedra di Ematologia CTMO Università degli Studi di Parma Parma
Italy S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo Pavia
Italy Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto Piacenza
Italy Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia Pisa
Italy Ematologia - Ospedale San Carlo Potenza
Italy Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli" Reggio Calabria
Italy Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova Reggio Emilia
Italy Ospedale "Infermi" Rimini
Italy U.O. di Ematologia - Centro Oncologico Basilicata Rionero in Vulture
Italy Università Cattolica del Sacro Cuore - Policlinico A. Gemelli Roma
Italy Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia Roma
Italy Università degli Studi - Policlinico di Tor Vergata Roma
Italy U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte" Siena
Italy Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino" Torino
Italy Clinica Ematologica-Centro Trapianti e Terapie cellulari Azienda Ospedaliero-Universitaria, Udine Udine
Italy Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi Verona
Italy ULSS N.6 Osp. S. Bortolo Vicenza

Sponsors (1)
Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients alive without progression Progression-free survival At 12 months from treatment start
Secondary Number of patients untreated Time-to-next treatment At 12 months from treatment start
Secondary Number of patients attaining Complete Response (CR) At six months, that is, at the end of the induction therapy.
Secondary Number of patients attainint CR/partial response (PR) At six months, that is, at the end of the induction therapy.
Secondary Number of patients alive At 12 months from treatment start
Secondary Number of patients with grade 3-4 adverse events At 12 months from treatment start
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