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

Primary Purpose

T-cell Lymphoma

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Bendamustine

About this trial

This is an interventional treatment trial for T-cell Lymphoma focused on measuring Bendamustine refractory or relapsed T-cell lymphoma.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dr Gandhi DAMAJ

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bendamustine

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Determination of the progression free survival (PFS), time to treatment failure (TTF), time to progression (TTP), overall survival (OS) and the duration of response.

Full Information

NCT ID

NCT00959686

First Posted

August 14, 2009

Last Updated

February 11, 2013

Sponsor

French Innovative Leukemia Organisation

Collaborators

Mundipharma Pte Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00959686

Brief Title

Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma

Acronym

BENTLY

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

French Innovative Leukemia Organisation

Collaborators

Mundipharma Pte Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

T-cell Lymphoma

Keywords

Bendamustine refractory or relapsed T-cell lymphoma.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bendamustine

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Bendamustine

Other Intervention Name(s)

Ribomustin®

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

36 months follow-up

Secondary Outcome Measure Information:

Title

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

Time Frame

36 months follow-up

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gandhi DAMAJ, MD MS

Organizational Affiliation

French Innovative Leukemia Organisation

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rémy GRESSIN, MD MS

Organizational Affiliation

French Innovative Leukemia Organisation

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

THierry LAMY, PD MS

Organizational Affiliation

French Innovative Leukemia Organisation

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Olivier TOURNILHAC, PD MS

Organizational Affiliation

French Innovative Leukemia Organisation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dr Gandhi DAMAJ

City

Amiens

ZIP/Postal Code

80054

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

23109692

Citation

Damaj G, Gressin R, Bouabdallah K, Cartron G, Choufi B, Gyan E, Banos A, Jaccard A, Park S, Tournilhac O, Schiano-de Collela JM, Voillat L, Joly B, Le Gouill S, Saad A, Cony-Makhoul P, Vilque JP, Sanhes L, Schmidt-Tanguy A, Bubenheim M, Houot R, Diouf M, Marolleau JP, Bene MC, Martin A, Lamy T. Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial. J Clin Oncol. 2013 Jan 1;31(1):104-10. doi: 10.1200/JCO.2012.43.7285. Epub 2012 Oct 29.

Results Reference

derived

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Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma

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