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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014