Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma (BENTLY)

This study has been completed.
Sponsor:
Collaborator:
Mundipharma Pte Ltd.
Information provided by (Responsible Party):
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier:
NCT00959686
First received: August 14, 2009
Last updated: February 11, 2013
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
T-cell Lymphoma
Drug: Bendamustine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma. A Phase II Multicenter Study "BENTLY"

Resource links provided by NLM:


Further study details as provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:

Primary Outcome Measures:
  • Determine the overall response rate (ORR) (CR+CRu+PR) [ Time Frame: 36 months follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of the tolerance and Safety of bendamustine in this subset of patients [ Time Frame: 36 months follow-up ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: September 2009
Study Completion Date: February 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Other Name: Ribomustin®

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959686

Locations
France
Dr Gandhi DAMAJ
Amiens, France, 80054
Sponsors and Collaborators
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Mundipharma Pte Ltd.
Investigators
Principal Investigator: Gandhi DAMAJ, MD MS Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Principal Investigator: Rémy GRESSIN, MD MS Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Principal Investigator: THierry LAMY, PD MS Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Principal Investigator: Olivier TOURNILHAC, PD MS Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
  More Information

Additional Information:
No publications provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier: NCT00959686     History of Changes
Other Study ID Numbers: "BENTLY"
Study First Received: August 14, 2009
Last Updated: February 11, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:
Bendamustine refractory or relapsed T-cell lymphoma.

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Bendamustine
Nitrogen Mustard Compounds
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014