New Combination Regimen of L-asparaginase, Dexamethasone, Ifosfamide, Cisplatin and Etoposide in NK/T-Cell Lymphoma

Phase II Study of L-asparaginase Plus DICE Regimen in Patients With Stage I/II NK/T-cell Lymphoma

The purpose of this study is to evaluate the efficacy and tolerability of the combination chemotherapy of L-asparaginase plus DICE regimen in the patients with early stage NK/T-cell lymphoma.

DICE regimen was found to be highly effective as induction chemotherapy in patients with early stage NK/T-cell lymphoma in the ongoing study. L-asparaginase, an agent with unique anti-cancer mechanism, was also found to be effective in salvage setting. In terms of non-overlapped efficacy and toxicity, the investigators designed this phase II study to verify the efficacy and tolerability of this new combination.

Inclusion Criteria:

• Age range 14-75 years old
• Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract
• ECOG performance status less than 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