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Gemcitabine for Marginal Zone Lymphoma

This study has been terminated.
(poor accrual and response less than expected on interim analysis)
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00337259
First received: June 14, 2006
Last updated: May 4, 2009
Last verified: May 2009
History of Changes
  Purpose

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 Intervention Phase
Non-Hodgkin's Lymphoma
Marginal Zone Lymphoma
 Drug: gemcitabine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Gemcitabine in Patients With Advanced Stage Marginal Zone B-Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

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
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: gemcitabine
    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

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

No publications provided

Responsible Party: Chairman, IRB, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00337259     History of Changes
Other Study ID Numbers: AMC 2006-60
Study First Received: June 14, 2006
Last Updated: May 4, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
marginal zone lymphoma
gemcitabine

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

ClinicalTrials.gov processed this record on May 19, 2013