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NCT Number: NCT00854425

L-asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma

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

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-Asparaginase

Drug

L-asparaginase 600mg/m2 days 1-7 repeated every 3 weeks for a total of 6 cycles

Other names: L-asp

Primary outcomes

  1. Response rate

    Time frame: 6 weeks

Secondary outcomes

  1. Progression-free survival and overall survival

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Mar 3, 2009
Registry last updated
Feb 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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