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Phase II Study of L-asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma


Phase 2
18 Years
75 Years
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Phase II Study of L-asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma


The prognosis of patients with progressive and recurrent NK/T cell lymphoma is poor
partially due to lack of effective treatment. L-asparaginase was reported to be effective in
this setting by several case reports. The investigators aim to evaluate the efficacy and
toxicity of L-asparaginase monotherapy in a prospective phase II study.


Inclusion Criteria:



- Age range 18-75 years old

- Histological confirmed NK/T cell lymphoma with progressive or recurrent disease

- ECOG performance status 0-2

- 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:

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:

L-asp-NK/T

NCT ID:

NCT00854425

Start Date:

June 2008

Completion Date:

January 2012

Related Keywords:

  • Lymphoma
  • Lymphoma
  • Lymphoma, T-Cell

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