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

Sponsor
Fudan University (Other)
Overall Status
Completed
CT.gov ID
NCT00854425
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
43
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of L-asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: L-asp

Drug: L-asparaginase
L-asparaginase 600mg/m2 days 1-7 repeated every 3 weeks for a total of 6 cycles
Other Names:
  • L-asp

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Response rate [6 weeks]

    Secondary Outcome Measures

    1. Progression-free survival and overall survival [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fudan University Cancer Hospital Shanghai Shanghai China 200032

    Sponsors and Collaborators

    • Fudan University

    Investigators

    • Principal Investigator: Ye Guo, MD, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ye Guo, Dr., Fudan University
    ClinicalTrials.gov Identifier:
    NCT00854425
    Other Study ID Numbers:
    • L-asp-NK/T
    First Posted:
    Mar 3, 2009
    Last Update Posted:
    Feb 20, 2012
    Last Verified:
    Feb 1, 2012
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, T-Cell
    Asparaginase

    Study Results

    No Results Posted as of Feb 20, 2012