Lymphoma
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and tolerability of L-asparaginase monotherapy as salvage treatment in patients with NK/T cell lymphoma
Detailed description
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.
Interventions
DRUGL-asparaginase
L-asparaginase 600mg/m2 days 1-7 repeated every 3 weeks for a total of 6 cycles
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival and overall survival | 2 years |
Countries
China
Outcome results
None listed