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

Phase 2
18 Years
Not Enrolling
Non-Hodgkin's Lymphoma, Marginal Zone Lymphoma

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Trial Information

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

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.

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

- Serious comorbid diseases

- Pregnancy or breast feeding

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Outcome Time Frame:

CR+PR with study therapy

Safety Issue:


Principal Investigator

Cheolwon Suh, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center


Korea: Food and Drug Administration

Study ID:

AMC 2006-60



Start Date:

June 2006

Completion Date:

March 2009

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Marginal Zone Lymphoma
  • marginal zone lymphoma
  • gemcitabine
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell, Marginal Zone