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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ye Guo, Fudan University
ClinicalTrials.gov Identifier:
NCT00854425
First received: March 2, 2009
Last updated: February 16, 2012
Last verified: February 2012
History of Changes

March 2, 2009
February 16, 2012
June 2008
January 2012   (final data collection date for primary outcome measure)
Response rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Response rate [ Time Frame: every two cycles ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00854425 on ClinicalTrials.gov Archive Site
Progression-free survival and overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
L-asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma
Phase II Study of 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

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.
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
Drug: L-asparaginase
L-asparaginase 600mg/m2 days 1-7 repeated every 3 weeks for a total of 6 cycles
Other Name: L-asp
Experimental: L-asp
Intervention: Drug: L-asparaginase
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00854425
L-asp-NK/T
No
Ye Guo, Fudan University
Fudan University
Not Provided
Principal Investigator: Ye Guo, MD Fudan University
Fudan University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP