L-asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma

NCT ID: NCT00854425

Last Updated: 2012-02-20

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-01-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and tolerability of L-asparaginase monotherapy as salvage treatment in patients with NK/T cell lymphoma

Detailed Description

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The prognosis of patients with progressive and recurrent NK/T cell lymphoma is poor partially due to lack of effective treatment. L-asparaginase was reported to be effective in this setting by several case reports. The investigators aim to evaluate the efficacy and toxicity of L-asparaginase monotherapy in a prospective phase II study.

Conditions

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Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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L-asp

Group Type EXPERIMENTAL

L-asparaginase

Intervention Type DRUG

L-asparaginase 600mg/m2 days 1-7 repeated every 3 weeks for a total of 6 cycles

Interventions

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L-asparaginase

L-asparaginase 600mg/m2 days 1-7 repeated every 3 weeks for a total of 6 cycles

Intervention Type DRUG

Other Intervention Names

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L-asp

Eligibility Criteria

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Inclusion Criteria

* Age range 18-75 years old
* Histological confirmed NK/T cell lymphoma with progressive or recurrent disease
* ECOG performance status 0-2
* Life expectancy of more than 3 months
* Normal laboratory values: hemoglobin \> 80 g/dl, neutrophil \> 2×109/L, platelet \> 100×109/L, serum creatine \< 1.5×upper limitation of normal (ULN), serum bilirubin \< 1.5×ULN, ALT and AST \< 2.5×ULN

Exclusion Criteria

* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
* The evidence of CNS metastasis
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Ye Guo

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ye Guo, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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L-asp-NK/T

Identifier Type: -

Identifier Source: org_study_id

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