Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma

Phase 2

Completed

• Conditions: T-cell Lymphoma
• Interventions: Drug: Bendamustine

• Registration Number: NCT00959686
• Lead Sponsor: French Innovative Leukemia Organisation

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).

Study Timeline

• Study First Submitted: 2009-08-14
• Study First Submitted QC: 2009-08-14
• Study First Posted: 2009-08-17
• Study Start: 2009-09
• Status Verified: 2011-06
• Primary Completion: 2011-06
• Study Completion: 2013-02
• Last Update Submitted: 2013-02-11
• Last Update Posted: 2013-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bendamustine	Bendamustine	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 Measures

Name	Time	Method
Determine the overall response rate (ORR) (CR+CRu+PR)	36 months follow-up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dr Gandhi DAMAJ; 🇫🇷 Amiens, France