Efficacy and Safety of Bendamustine Plus Rituximab in Chronic Lympocytic Leukemia (LLC1315)

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Completed

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Bendamustine + Rituximab

Study type: Observational

Funder types: Other

Identifiers

NCT02491398

LLC1315

Details and patient eligibility

About

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.

Full 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.

Enrollment: 494 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

494 participants in 2 patient groups

First-line

Description:

Previously untreated CLL requiring therapy according to the NCI criteria and treated with at least one cycle of BR as first-line treatment.

Treatment:

Drug: Bendamustine + Rituximab

Second-line

Description:

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.

Treatment:

Drug: Bendamustine + Rituximab