L-asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma
- Registration Number
- NCT00854425
- Lead Sponsor
- Fudan University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description L-asp L-asparaginase -
- Primary Outcome Measures
Name Time Method Response rate 6 weeks
- Secondary Outcome Measures
Name Time Method Progression-free survival and overall survival 2 years
Trial Locations
- Locations (1)
Fudan University Cancer Hospital
🇨🇳Shanghai, Shanghai, China