Phase II Study of L-asparaginase Plus DICE Regimen in Patients With Stage I/II NK/T-cell Lymphoma
14 Years
75 Years
Both
Lymphoma
Trial Information
Phase II Study of L-asparaginase Plus DICE Regimen in Patients With Stage I/II 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
complete response rate
Outcome Time Frame:
6 weeks
Safety Issue:
No
Principal Investigator
Ye Guo, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fudan University
Authority:
China: Ethics Committee
Study ID:
LMTG 09-02
NCT ID:
NCT00933673
Start Date:
June 2009
Completion Date:
June 2012
Related Keywords:
- Lymphoma
- NK/T cell lymphoma
- DICE
- L-asparaginase
- Lymphoma
- Lymphoma, T-Cell
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