Relapsed or Refractory Chronic Lymphoproliferative Disorders Clinical Trial
Official title:
A Retrospective Multicenter Trial on Efficacy and Toxicity of Bendamustine Alone or Associated With Rituximab, as Salvage Therapy in Patients With Chronic Lymphoproliferative Disorders
| Verified date | October 2010 |
| Source | Gruppo Italiano Studio Linfomi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Observational |
This retrospective study collects and evaluates the clinical experience reached in Italy on the use of bendamustine alone or combined with rituximab as treatment of patients with relapsed or refractory chronic lymphoproliferative disorders.
| Status | Completed |
| Enrollment | 109 |
| Est. completion date | December 2009 |
| Est. primary completion date | December 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - patients with relapsed or refractory chronic lymphoproliferative disorders - salvage treatment with bendamustine +/- rituximab - age = 18 years Exclusion Criteria: - previous treatment with bendamustine |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Italy | Gruppo Italiano Studio Linfomi | Modena |
| Lead Sponsor | Collaborator |
|---|---|
| Gruppo Italiano Studio Linfomi |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | overall response rate | within 1 month after end of treatment | No | |
| Secondary | grade III and IV (NCI Common Toxicity Criteria) adverse events | within 1 month after end of treatment | Yes | |
| Secondary | prognostic factors | within 1 month after end of treatment | No | |
| Secondary | progression free survival | within 1 month after end of treatment | No | |
| Secondary | overall survival | within 1 month after end of treatment | No |