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Completed

NCT Number: NCT00959686

Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma

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

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Key information

Conditions

T-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dr Gandhi DAMAJ

Amiens, 80054, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bendamustine

Drug

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

Other names: Ribomustin®

Primary outcomes

  1. Determine the overall response rate (ORR) (CR+CRu+PR)

    Time frame: 36 months follow-up

Secondary outcomes

  1. Evaluation of the tolerance and Safety of bendamustine in this subset of patients

    Time frame: 36 months follow-up

  2. 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

Sponsors and collaborators

Lead sponsor

French Innovative Leukemia Organisation

Other

Collaborators

  • Mundipharma Pte Ltd.

Registry information

Official study title

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

Acronym: BENTLY

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Aug 17, 2009
Registry last updated
Feb 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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