Study on the Combination Regimen of Dexamethasone Ifosfamide Cisplatin Etoposide in Patients With NK/T Cell Lymphoma

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Lymphoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00568607

DICE-NK/T

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and tolerability of the combination chemotherapy of DICE in the patients with NK/T cell lymphoma.

Full description

Patients with NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP.The investigators did this trial to evaluate the efficacy and tolerability of the combination chemotherapy of DICE in the patients with NK/T cell lymphoma.

Enrollment: 60 estimated 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
• ECOG performance status less than 2
• Life expectancy of more than 3 months
• None of major drugs in the trial (IFO,VP16,DDP) has been previously used
• 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: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

IFO, VP-16, DDP, DXM

Experimental group

Treatment:

Drug: IFO, VP-16, DDP, DXM