Chronic Lymphocytic Leukemia
Conditions
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.
Interventions
Sponsors
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients alive without progression | At 12 months from treatment start | Progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients untreated | At 12 months from treatment start | Time-to-next treatment |
| 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 | — |
Countries
Italy
Outcome results
None listed