Gemcitabine for Marginal Zone Lymphoma - Full Text View

Sponsors and Collaborators:	Asan Medical Center Eli Lilly and Company
Information provided by:	Asan Medical Center
ClinicalTrials.gov Identifier:	NCT00337259

Purpose

Marginal zone lymphoma, one of the indolent lymphoma, is believed to be incurable with chemotherapy. Thus we 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 our knowledge, there has been no trial of gemcitabine for marginal zone lymphoma. Thus we made a plan to investigate the role of gemcitabine in marginal zone lymphoma.

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma	Drug: gemcitabine	Phase II

MedlinePlus related topics: Lymphoma

Drug Information available for: Gemcitabine hydrochloride Gemcitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Gemcitabine in Patients With Advanced Stage Marginal Zone B-Cell Lymphoma

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:

response rate [ Time Frame: CR+PR with study therapy ] [ Designated as safety issue: No ]
duration of response [ Time Frame: from best response to progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

safety and tolerability of the treatment [ Time Frame: toxicity due to stdy drug ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	43
Study Start Date:	June 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

D1 and 8, Gemcitabine 1250mg/m2 + NS 100ml MIV over 30min, every 3 weeks

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337259

Contacts

Contact: Cheolwon Suh, MD, PhD

+82 2 3010 3209

csuh@amc.seoul.kr

Locations

Korea, Republic of
Asan Medical Center	Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Cheolwon Suh, MD, PhD +82 2 3010 3209 csuh@amc.seoul.kr

Sponsors and Collaborators

Asan Medical Center

Eli Lilly and Company

Investigators

Principal Investigator:

Cheolwon Suh, MD, PhD

Asan Medical Center

More Information

Responsible Party:	IRB, Asan Medical Center ( Chairman )
Study ID Numbers:	AMC 2006-60
Study First Received:	June 14, 2006
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00337259
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:

marginal zone lymphoma
gemcitabine

Study placed in the following topic categories:

Lymphoma, B-Cell
Lymphatic Diseases
Immunoproliferative Disorders
B-cell lymphomas
Lymphoma, small cleaved-cell, diffuse

Lymphoma, B-Cell, Marginal Zone
Gemcitabine
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009