Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma (BENTLY)

French Innovative Leukemia Organisation

Status and phase

Completed

Phase 2

Conditions

T-cell Lymphoma

Treatments

Drug: Bendamustine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00959686

"BENTLY"

Details and patient eligibility

About

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

Full 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).

Enrollment

45 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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