Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-02-28

Brief Summary

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

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Detailed Description

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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).

Conditions

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T-cell Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bendamustine

Bendamustine at the dose of 120 mg/m2 IV over 60 minutes on days 1 and 2 every 21 days for 6 cycles

Group Type EXPERIMENTAL

Bendamustine

Intervention Type DRUG

Bendamustine at the dose of 120 mg/m2 IV over 60 minutes on days 1 and 2 every 21 days for 6 cycles

Interventions

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Bendamustine

Bendamustine at the dose of 120 mg/m2 IV over 60 minutes on days 1 and 2 every 21 days for 6 cycles

Intervention Type DRUG

Other Intervention Names

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Ribomustin®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No