Brief Title
Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma
Official Title
Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma. A Phase II Multicenter Study "BENTLY"
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 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).
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Determine the overall response rate (ORR) (CR+CRu+PR)
Secondary Outcome
Evaluation of the tolerance and Safety of bendamustine in this subset of patients
Condition
T-cell Lymphoma
Intervention
Bendamustine
Study Arms / Comparison Groups
Bendamustine
Description: Bendamustine at the dose of 120 mg/m2 IV over 60 minutes on days 1 and 2 every 21 days for 6 cycles
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
45
Start Date
September 2009
Completion Date
February 2013
Primary Completion Date
June 2011
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Gandhi DAMAJ, MD MS, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00959686
Organization ID
"BENTLY"
Responsible Party
Sponsor
Study Sponsor
French Innovative Leukemia Organisation
Collaborators
Mundipharma Pte Ltd.
Study Sponsor
Gandhi DAMAJ, MD MS, Principal Investigator, French Innovative Leukemia Organisation
Verification Date
June 2011