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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00854425
• Other study ID #: L-asp-NK/T
• Status: Completed
• Phase: Phase 2
• First received: March 2, 2009
• Last updated: February 16, 2012
• Start date: June 2008
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		6 weeks	No
Secondary	Progression-free survival and overall survival		2 years	No