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"

A Phase II clinical study to determine the efficacy of single agent Bendamustine for T cell lymphoma "BENTLY".

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).

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