NCT00959686

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2009

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

February 12, 2013

Status Verified

June 1, 2011

Enrollment Period

1.7 years

First QC Date

August 14, 2009

Last Update Submit

February 11, 2013

Conditions

T-cell Lymphoma

Keywords

Bendamustine refractory or relapsed T-cell lymphoma.

Outcome Measures

Primary Outcomes (1)

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

    36 months follow-up

Secondary Outcomes (2)

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

    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.

    36 months follow-up

Study Arms (1)

Bendamustine

EXPERIMENTAL

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

Interventions

BendamustineDRUG

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

Also known as: Ribomustin®
Bendamustine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Gandhi DAMAJ

Amiens, 80054, France

Location

Related Publications (1)

  • 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.

    PMID: 23109692DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell

Interventions

Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

ButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2009

First Posted

August 17, 2009

Study Start

September 1, 2009

Primary Completion

June 1, 2011

Study Completion

February 1, 2013

Last Updated

February 12, 2013

Record last verified: 2011-06

Locations

FR(1)