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

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Lymphoma

Treatments: Drug: L-asp, DXM, IFO, VP-16, DDP

Study type: Interventional

Funder types: Other

Identifiers

NCT00933673

LMTG 09-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 76 estimated patients

Sex: All

Ages: 14 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

L-DICE

Experimental group

Treatment:

Drug: L-asp, DXM, IFO, VP-16, DDP