Gemcitabine for Marginal Zone Lymphoma

Phase 2

Terminated

• Conditions: Non-Hodgkin's Lymphoma; Marginal Zone Lymphoma
• Interventions: Drug: gemcitabine

• Registration Number: NCT00337259
• Lead Sponsor: Asan Medical Center

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 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.

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 Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-14
• Study First Submitted QC: 2006-06-14
• Study First Posted: 2006-06-15
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-13
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 43

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
response rate	CR+PR with study therapy

Secondary Outcome Measures

Name	Time	Method
safety and tolerability of the treatment	toxicity due to stdy drug

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of