Know Cancer

forgot password

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

Phase 2
14 Years
75 Years
Open (Enrolling)

Thank you

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:


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:


Principal Investigator

Ye Guo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Ethics Committee

Study ID:

LMTG 09-02



Start Date:

June 2009

Completion Date:

June 2012

Related Keywords:

  • Lymphoma
  • NK/T cell lymphoma
  • DICE
  • L-asparaginase
  • Lymphoma
  • Lymphoma, T-Cell