Gemcitabine for Marginal Zone Lymphoma

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; (submitted: February 13, 2016)	response rate [ Time Frame: CR+PR with study therapy ]
Original Primary Outcome Measures ICMJE; (submitted: June 14, 2006)	response rate; duration of response
Change History	Complete list of historical versions of study NCT00337259 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 30, 2007)	safety and tolerability of the treatment [ Time Frame: toxicity due to stdy drug ]
Original Secondary Outcome Measures ICMJE; (submitted: June 14, 2006)	safety and tolerability of the treatment; progression free survival; overall survival
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	Non-Hodgkin's Lymphoma; Marginal Zone Lymphoma
Intervention ICMJE	Drug: gemcitabine; D1 and 8, Gemcitabine 1250mg/m2 + NS 100ml MIV over 30min, every 3 weeks
Study Arms	Experimental: Gemcitabine; histologically confirmed marginal zone lymphoma; gemcitabine 1,250 mg/m2 on days 1 and 8 of each cycle, repeated every 3 weeks and continued for 6 cycles, until disease progression, withdrawal due to toxicity, or withdrawal of consent.; 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; (submitted: June 14, 2006)	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: Histologically confirmed marginal zone B-cell lymphoma; Performance status (ECOG) ≤3; Age ≥ 18; At least one or more bidimensionally measurable lesion(s): 2 cm by conventional CT 1 cm by spiral CT skin lesion (photographs should be taken) measurable lesion by physical examination; Laboratory values: Cr < 2.0 mg% or Ccr > 60 ml/min Transaminase < 3 X upper normal value Bilirubin < 2 mg% ANC > 1500/ul, platelet > 75,000/ul; Informed consent; Ann Arbor stage III or IV Exclusion Criteria: Any other malignancies within the past 5 years except skin basal cell ca or CIS of cervix; Serious comorbid diseases; Pregnancy or breast feeding
Sex/Gender	Sexes Eligible for Study: All
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	Plan to Share IPD: No
Responsible Party	Cheolwon Suh, Asan Medical Center
Study Sponsor ICMJE	Asan Medical Center
Collaborators ICMJE	Eli Lilly and Company
Investigators ICMJE	Principal Investigator: Cheolwon Suh, MD, PhD Asan Medical Center
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