Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French Innovative Leukemia Organisation
• Collaborator: Mundipharma Pte Ltd.
• Treatments: Bendamustine Hydrochloride

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