Efficacy and Safety of Bendamustine Plus Rituximab in Chronic Lympocytic Leukemia

Completed

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Drug: Bendamustine + Rituximab

• Registration Number: NCT02491398
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-07-03
• Study First Submitted QC: 2015-07-03
• Study First Posted: 2015-07-08
• Study Start: 2016-02
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 494

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Second-line	Bendamustine + Rituximab	CLL 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 and treated with at least one cycle of BR.
First-line	Bendamustine + Rituximab	Previously untreated CLL requiring therapy according to the NCI criteria and treated with at least one cycle of BR as first-line treatment.

Primary Outcome Measures

Name	Time	Method
Number of patients alive without progression	At 12 months from treatment start	Progression-free survival

Secondary Outcome Measures

Name	Time	Method
Number of patients with grade 3-4 adverse events	At 12 months from treatment start
Number of patients untreated	At 12 months from treatment start	Time-to-next treatment
Number of patients alive	At 12 months from treatment start
Number of patients attaining Complete Response (CR)	At six months, that is, at the end of the induction therapy.
Number of patients attainint CR/partial response (PR)	At six months, that is, at the end of the induction therapy.

Trial Locations

Locations (41)

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

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