Status:

TERMINATED

Gemcitabine for Marginal Zone Lymphoma

Lead Sponsor:

Asan Medical Center

Collaborating Sponsors:

Eli Lilly and Company

Conditions:

Non-Hodgkin's Lymphoma

Marginal Zone Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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...

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 t...

Eligibility Criteria

Inclusion

  • 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

  • Any other malignancies within the past 5 years except skin basal cell ca or CIS of cervix
  • Serious comorbid diseases
  • Pregnancy or breast feeding

Key Trial Info

Start Date :

June 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2009

Estimated Enrollment :

43 Patients enrolled

Trial Details

Trial ID

NCT00337259

Start Date

June 1 2006

End Date

March 1 2009

Last Update

February 17 2016

Active Locations (1)

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1

Asan Medical Center

Seoul, South Korea, 138-736