Status:
UNKNOWN
New Combination Regimen of L-asparaginase, Dexamethasone, Ifosfamide, Cisplatin and Etoposide in NK/T-Cell Lymphoma
Lead Sponsor:
Fudan University
Conditions:
Lymphoma
Eligibility:
All Genders
14-75 years
Phase:
PHASE2
Brief Summary
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.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00933673
Start Date
June 1 2009
End Date
June 1 2012
Last Update
February 20 2012
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032