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

Fudan University

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Drug: L-asparaginase

Study type: Interventional

Funder types: Other

Identifiers

NCT00854425

L-asp-NK/T

Details and patient eligibility

About

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

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

L-asp

Experimental group

Treatment:

Drug: L-asparaginase