Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma

Overview

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

Full Title of Study: “Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma. A Phase II Multicenter Study “BENTLY””

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2011

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).

Interventions

  • Drug: Bendamustine
    • Bendamustine at the dose of 120 mg/m2 IV over 60 minutes on days 1 and 2 every 21 days for 6 cycles

Arms, Groups and Cohorts

  • Experimental: Bendamustine
    • Bendamustine at the dose of 120 mg/m2 IV over 60 minutes on days 1 and 2 every 21 days for 6 cycles

Clinical Trial Outcome Measures

Primary Measures

  • Determine the overall response rate (ORR) (CR+CRu+PR)
    • Time Frame: 36 months follow-up

Secondary Measures

  • Evaluation of the tolerance and Safety of bendamustine in this subset of patients
    • Time Frame: 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.
    • Time Frame: 36 months follow-up

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • French Innovative Leukemia Organisation
  • Collaborator
    • Mundipharma Pte Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gandhi DAMAJ, MD MS, Principal Investigator, French Innovative Leukemia Organisation
    • Rémy GRESSIN, MD MS, Principal Investigator, French Innovative Leukemia Organisation
    • THierry LAMY, PD MS, Principal Investigator, French Innovative Leukemia Organisation
    • Olivier TOURNILHAC, PD MS, Principal Investigator, French Innovative Leukemia Organisation

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