Efficacy and Safety of Bendamustine Plus Rituximab in Chronic Lympocytic Leukemia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: Bendamustine + Rituximab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| First-line<br>Previously untreated CLL requiring therapy according to the NCI criteria and treated with at least one cycle of BR as first-line treatment. | Drug: Bendamustine + Rituximab<br> <br> |
| Second-line<br>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. | Drug: Bendamustine + Rituximab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients alive without progression | Progression-free survival | At 12 months from treatment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients untreated | Time-to-next treatment | 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. | 
| Number of patients alive |  | At 12 months from treatment start | 
| Number of patients with grade 3-4 adverse events |  | At 12 months from treatment start |