L-asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma
Information source: Fudan University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma
Intervention: L-asparaginase (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Fudan University Official(s) and/or principal investigator(s): Ye Guo, MD, Principal Investigator, Affiliation: Fudan University
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
Clinical Details
Official title: Phase II Study of L-asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Response rate
Secondary outcome: Progression-free survival and overall survival
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Fudan University Cancer Hospital, Shanghai, Shanghai 200032, China
Additional Information
Starting date: June 2008
Last updated: February 16, 2012
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