Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma

T-cell Lymphoma Clinical Trial

— BENTLY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959686
• Other study ID #: "BENTLY"
• Status: Completed
• Phase: Phase 2
• First received: August 14, 2009
• Last updated: February 11, 2013
• Start date: September 2009
• Est. completion date: February 2013

Study information

• Verified date: June 2011
• Source: French Innovative Leukemia Organisation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2013
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• T-cell Lymphoma

Intervention

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

Locations

Country	Name	City	State
France	Dr Gandhi DAMAJ	Amiens

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS	Mundipharma Pte Ltd.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the overall response rate (ORR) (CR+CRu+PR)		36 months follow-up	Yes
Secondary	Evaluation of the tolerance and Safety of bendamustine in this subset of patients		36 months follow-up	Yes
Secondary	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	Yes