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

February 11, 2013 updated by: French Innovative Leukemia Organisation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • Dr Gandhi DAMAJ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Ribomustin®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Innovative Leukemia Organisation

Collaborators

Mundipharma Pte Ltd.

Investigators

  • Principal Investigator: Gandhi DAMAJ, MD MS, French Innovative Leukemia Organisation
  • Principal Investigator: Rémy GRESSIN, MD MS, French Innovative Leukemia Organisation
  • Principal Investigator: THierry LAMY, PD MS, French Innovative Leukemia Organisation
  • Principal Investigator: Olivier TOURNILHAC, PD MS, French Innovative Leukemia Organisation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

August 14, 2009

First Submitted That Met QC Criteria

August 14, 2009

First Posted (ESTIMATE)

August 17, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 11, 2013

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • "BENTLY"

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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