Clinical trial NCT00959686: Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma
Official title: Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma. A Phase II Multicenter Study "BENTLY"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: T-cell Lymphoma
Keywords: Bendamustine refractory or relapsed T-cell lymphoma.
Lead sponsor: French Innovative Leukemia Organisation
Sponsor class: OTHER
Collaborators: name: Mundipharma Pte Ltd.
First posted: 2009-08-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Determine the overall response rate (ORR) (CR+CRu+PR)
timeFrame: 36 months follow-up
Secondary outcomes:
measure: Evaluation of the tolerance and Safety of bendamustine in this subset of patients
timeFrame: 36 months follow-up
measure: Determination of the progression free survival (PFS), time to treatment failure (TTF), time to progression (TTP), overall survival (OS) and the duration of response.
timeFrame: 36 months follow-up
Other outcomes:
Locations:
city: Amiens
country: France
facility: Dr Gandhi DAMAJ
Study officials:
affiliation: French Innovative Leukemia Organisation
name: Gandhi DAMAJ, MD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: French Innovative Leukemia Organisation
name: Rémy GRESSIN, MD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: French Innovative Leukemia Organisation
name: THierry LAMY, PD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: French Innovative Leukemia Organisation
name: Olivier TOURNILHAC, PD MS
role: PRINCIPAL_INVESTIGATOR
References:
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.