Status:
COMPLETED
Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma
Lead Sponsor:
French Innovative Leukemia Organisation
Collaborating Sponsors:
Mundipharma Pte Ltd.
Conditions:
T-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 treatm...
Eligibility Criteria
Inclusion
- Patients aged more than 18 years.
- Refractory or relapsed peripheral T-cell NHL (PTCL)
- Cutaneous T cell lymphoma (CTCL) in relapse or refractory to topical therapy
- ECOG score less than 2
- No major organ dysfunction unrelated to lymphoma.
Exclusion
- Pregnant or breast feeding women
- ECOG score \> 2
- Estimate survival time \< 3 months
- Active infection or severe organ dysfunction or psychiatric condition that unable patients to receive chemotherapy
- Creatinine clearance \< 10 ml/min or severe hepatic dysfunction not related to lymphoma.
- Previous chemotherapy/immunotherapy within 3 weeks before study entry
- Known seropositive for or active viral infection HIV, EBV, HCV
- CNS lymphoma
- T-cell Leukemia lymphoma associated with HTLV1
- Sezary syndrome
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2013
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00959686
Start Date
September 1 2009
End Date
February 1 2013
Last Update
February 12 2013
Active Locations (1)
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1
Dr Gandhi DAMAJ
Amiens, France, 80054