NCT00959686CompletedPhase 2
Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma. A Phase II Multicenter Study "BENTLY"
French Innovative Leukemia Organisation1 site in 1 country45 target enrollmentStarted: September 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Determine the overall response rate (ORR) (CR+CRu+PR)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Bendamustine (Drug)
Outcomes
Primary Outcomes
Determine the overall response rate (ORR) (CR+CRu+PR)
Time Frame: 36 months follow-up
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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