Efficacy and Safety of Bendamustine Plus Rituximab in Chronic Lympocytic Leukemia

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.

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.