Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00959686

Acronym

BENTLY

Enrollment

Registered

2009-08-17

Start date

2009-09-30

Completion date

2013-02-28

Last updated

2013-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T-cell Lymphoma

Keywords

Bendamustine refractory or relapsed T-cell lymphoma.

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).

Interventions

DRUGBendamustine

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Determine the overall response rate (ORR) (CR+CRu+PR)	36 months follow-up

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026