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Gemcitabine for Marginal Zone Lymphoma

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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
Eli Lilly and Company
Information provided by (Responsible Party):
Cheolwon Suh, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Marginal Zone Lymphoma Drug: gemcitabine Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Gemcitabine in Patients With Advanced Stage Marginal Zone B-cell Lymphoma
Study Start Date : June 2006
Primary Completion Date : March 2009
Study Completion Date : March 2009

Arm Intervention/treatment
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.
Drug: gemcitabine
D1 and 8, Gemcitabine 1250mg/m2 + NS 100ml MIV over 30min, every 3 weeks

Primary Outcome Measures :
  1. response rate [ Time Frame: CR+PR with study therapy ]

Secondary Outcome Measures :
  1. safety and tolerability of the treatment [ Time Frame: toxicity due to stdy drug ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00337259

Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Eli Lilly and Company
Principal Investigator: Cheolwon Suh, MD, PhD Asan Medical Center

Responsible Party: Cheolwon Suh, ASCT team, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00337259     History of Changes
Other Study ID Numbers: AMC 2006-60
First Posted: June 15, 2006    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Cheolwon Suh, Asan Medical Center:
marginal zone lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs