NCT00854425

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_2 lymphoma

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 20, 2012

Status Verified

February 1, 2012

Enrollment Period

3.6 years

First QC Date

March 2, 2009

Last Update Submit

February 16, 2012

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Response rate

    6 weeks

Secondary Outcomes (1)

  • Progression-free survival and overall survival

    2 years

Study Arms (1)

L-asp

EXPERIMENTAL
Drug: L-asparaginase

Interventions

L-asparaginaseDRUG

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

Also known as: L-asp
L-asp

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Lymphoma

Interventions

Asparaginase

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

AmidohydrolasesHydrolasesEnzymesEnzymes and Coenzymes

Study Officials

  • Ye Guo, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 2, 2009

First Posted

March 3, 2009

Study Start

June 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 20, 2012

Record last verified: 2012-02

Locations

CN(1)