Overview
Efficacy and Safety of Bendamustine Plus Rituximab in Chronic Lympocytic Leukemia
Status:
Completed
Completed
Trial end date:
2017-01-01
2017-01-01
Target enrollment:
0
0
Participant gender:
All
All
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.Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'AdultoTreatments:
Bendamustine Hydrochloride
Rituximab
Criteria
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.