Gemcitabine for Marginal Zone Lymphoma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00337259 |
Recruitment Status
:
Terminated
(poor accrual and response less than expected on interim analysis)
First Posted
: June 15, 2006
Last Update Posted
: February 17, 2016
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | June 14, 2006 | |||
First Posted Date ICMJE | June 15, 2006 | |||
Last Update Posted Date | February 17, 2016 | |||
Study Start Date ICMJE | June 2006 | |||
Actual Primary Completion Date | March 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
response rate [ Time Frame: CR+PR with study therapy ] | |||
Original Primary Outcome Measures ICMJE |
|
|||
Change History | Complete list of historical versions of study NCT00337259 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
safety and tolerability of the treatment [ Time Frame: toxicity due to stdy drug ] | |||
Original Secondary Outcome Measures ICMJE |
|
|||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Gemcitabine for Marginal Zone Lymphoma | |||
Official Title ICMJE | Phase II Study of Gemcitabine in Patients With Advanced Stage Marginal Zone B-cell Lymphoma | |||
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. |
|||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE |
|
|||
Intervention ICMJE | Drug: gemcitabine
D1 and 8, Gemcitabine 1250mg/m2 + NS 100ml MIV over 30min, every 3 weeks |
|||
Study Arms | Experimental: Gemcitabine
Intervention: Drug: gemcitabine |
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
43 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | March 2009 | |||
Actual Primary Completion Date | March 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00337259 | |||
Other Study ID Numbers ICMJE | AMC 2006-60 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement |
|
|||
Responsible Party | Cheolwon Suh, Asan Medical Center | |||
Study Sponsor ICMJE | Asan Medical Center | |||
Collaborators ICMJE | Eli Lilly and Company | |||
Investigators ICMJE |
|
|||
PRS Account | Asan Medical Center | |||
Verification Date | February 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |