A Phase II clinical study to determine the efficacy of single agent Bendamustine for T cell lymphoma "BENTLY".
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Bendamustine at the dose of 120 mg/m2 IV over 60 minutes on days 1 and 2 every 21 days for 6 cycles
Dr Gandhi DAMAJ
Amiens, France
Determine the overall response rate (ORR) (CR+CRu+PR)
Time frame: 36 months follow-up
Evaluation of the tolerance and Safety of bendamustine in this subset of patients
Time frame: 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.
Time frame: 36 months follow-up
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