Gemcitabine for Marginal Zone Lymphoma

• Status: Terminated
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: Eli Lilly and Company
• Treatments: Gemcitabine

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