Trials / Completed
CompletedNCT00959686
Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma
Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma. A Phase II Multicenter Study "BENTLY"
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- French Innovative Leukemia Organisation · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A Phase II clinical study to determine the efficacy of single agent Bendamustine for T cell lymphoma "BENTLY".
Detailed description
The primary objective of this study is to define the activity of Bendamustine for the treatment of T cells lymphomas. The activity of Bendamustine is determined by the response rate (RR) to the treatment within 22 days after intravenous infusion which enables to get a confidence interval of 95 % for the probability of an overall response rate (ORR).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bendamustine | Bendamustine at the dose of 120 mg/m2 IV over 60 minutes on days 1 and 2 every 21 days for 6 cycles |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2011-06-01
- Completion
- 2013-02-01
- First posted
- 2009-08-17
- Last updated
- 2013-02-12
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT00959686. Inclusion in this directory is not an endorsement.