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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

Page last updated: August 20, 2015

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