Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma

Study Overview
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Brief Summary
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A Phase II clinical study to determine the efficacy of single agent Bendamustine for T cell lymphoma BENTLY.

Detailed Description
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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).

Official Title
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Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma. A Phase II Multicenter Study BENTLY

Conditions
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T-cell Lymphoma

Intervention / Treatment
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* Drug: Bendamustine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bendamustine<br>Bendamustine at the dose of 120 mg/m2 IV over 60 minutes on days 1 and 2 every 21 days for 6 cycles | Drug: Bendamustine<br>* Bendamustine at the dose of 120 mg/m2 IV over 60 minutes on days 1 and 2 every 21 days for 6 cycles<br>* Other names: Ribomustin®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the overall response rate (ORR) (CR+CRu+PR) |  | 36 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the tolerance and Safety of bendamustine in this subset of patients |  | 36 months follow-up | 
| Determination of the progression free survival (PFS), time to treatment failure (TTF), time to progression (TTP), overall survival (OS) and the duration of response. |  | 36 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bendamustine refractory or relapsed T-cell lymphoma.