Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-25 @ 5:49 PM
Study NCT ID:
NCT00337259
Status:
TERMINATED
Last Update Posted:
2016-02-17
First Post:
2006-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gemcitabine for Marginal Zone Lymphoma
Sponsor:
Asan Medical Center
Organization:
Study Overview
Official Title:
Phase II Study of Gemcitabine in Patients With Advanced Stage Marginal Zone B-cell Lymphoma
Status:
TERMINATED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor accrual and response less than expected on interim analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Marginal zone lymphoma, one of the indolent lymphoma, is believed to be incurable with chemotherapy. Thus the investigators need a novel agent for marginal zone lymphoma. Gemcitabine has been tried as one of salvage chemotherapy regimen and has been shown to have anti-lymphoma activity. To the investigators' knowledge, there has been no trial of gemcitabine for marginal zone lymphoma. Thus the investigators made a plan to investigate the role of gemcitabine in marginal zone lymphoma.
Detailed Description:
We designed a multi-center phase II trial of gemcitabine for advanced stage marginal zone B-cell lymphoma. Marginal zone lymphoma needs novel agent to improve clinical course by chemotherapy. Recent trials with new agents for indolent lymphoma shows promising results. Gemcitabine is known to have activity to non-Hodgkin's lymphoma and has less adverse effects than other new agents. With this background gemcitabine will be tried as a single agent for advanced marginal zone lymphoma.
Gemcitabine will be administered with 1,250mg/sq.m on days 1 and 8 every 3 weeks. Response will be assessed by IWC criteria.
Gemcitabine will be administered with 1,250mg/sq.m on days 1 and 8 every 3 weeks. Response will be assessed by IWC criteria.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: