Gemcitabine for Marginal Zone Lymphoma

February 13, 2016 updated by: Cheolwon Suh, Asan Medical Center

Phase II Study of Gemcitabine in Patients With Advanced Stage Marginal Zone B-cell Lymphoma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
response rate
Time Frame: CR+PR with study therapy
CR+PR with study therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
safety and tolerability of the treatment
Time Frame: toxicity due to stdy drug
toxicity due to stdy drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Eli Lilly and Company

Investigators

  • Principal Investigator: Cheolwon Suh, MD, PhD, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

June 14, 2006

First Submitted That Met QC Criteria

June 14, 2006

First Posted (Estimate)

June 15, 2006

Study Record Updates

Last Update Posted (Estimate)

February 17, 2016

Last Update Submitted That Met QC Criteria

February 13, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC 2006-60

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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