Back to resultsL-asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
L-asparaginase
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma
Eligibility 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
Sites / Locations
- Fudan University Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
L-asp
Arm Description
Outcomes
Primary Outcome Measures
Response rate
Secondary Outcome Measures
Progression-free survival and overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00854425
Brief Title
L-asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma
Official Title
Phase II Study of L-asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L-asp
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
L-asparaginase
Other Intervention Name(s)
L-asp
Intervention Description
L-asparaginase 600mg/m2 days 1-7 repeated every 3 weeks for a total of 6 cycles
Primary Outcome Measure Information:
Title
Response rate
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Progression-free survival and overall survival
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ye Guo, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Learn more about this trial
L-asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma
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