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

This study is currently recruiting participants.

Verified by Fudan University, March 2009

First Received: March 2, 2009 No Changes Posted

Sponsored by:	Fudan University
Information provided by:	Fudan University
ClinicalTrials.gov Identifier:	NCT00854425

Purpose

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	Intervention	Phase
Lymphoma	Drug: L-asparaginase	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Phase II Study of L-Asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: L-Asparaginase

U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:

Response rate [ Time Frame: every two cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival and overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
L-asp: Experimental	Drug: L-asparaginase L-asparaginase 600mg/m2 days 1-7 repeated every 3 weeks for a total of 6 cycles

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. We aim to evaluate the efficacy and toxicity of L-asparaginase monotherapy in a prospective phase II study.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854425

Contacts

Contact: Ye Guo, MD

pattrick_guo@msn.com

Locations

China
Fudan University Cancer Hospital	Recruiting
Shanghai, China, 200032
Contact: Ye Guo, MD

Sponsors and Collaborators

Fudan University

Investigators

Principal Investigator:

Ye Guo, MD

Fudan University Cancer Hospital

More Information

No publications provided

Responsible Party:	Fudan University Cancer Hospital ( Base for Drug Clinical Trials, Fudan University Cancer Hospital )
Study ID Numbers:	L-asp-NK/T
Study First Received:	March 2, 2009
Last Updated:	March 2, 2009
ClinicalTrials.gov Identifier:	NCT00854425 History of Changes
Health Authority:	China: Ethics Committee

Study placed in the following topic categories:

Asparaginase
Lymphatic Diseases
Immunoproliferative Disorders
Lymphoma, T-Cell

Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Asparaginase
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Pharmacologic Actions
Lymphatic Diseases

Neoplasms
Lymphoma, T-Cell
Therapeutic Uses
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on September 11, 2009