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


Phase 2
18 Years
N/A
Not Enrolling
Both
T-cell Lymphoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine the overall response rate (ORR) (CR+CRu+PR)

Outcome Time Frame:

36 months follow-up

Safety Issue:

Yes

Principal Investigator

Gandhi DAMAJ, MD MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

"BENTLY"

NCT ID:

NCT00959686

Start Date:

September 2009

Completion Date:

February 2013

Related Keywords:

  • T-Cell Lymphoma
  • Bendamustine refractory or relapsed T-cell lymphoma.
  • Lymphoma
  • Lymphoma, T-Cell

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