Gemcitabine for Marginal Zone Lymphoma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-Hodgkin's Lymphoma, Marginal Zone Lymphoma

Intervention / Treatment
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* Drug: gemcitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine<br>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<br>* D1 and 8, Gemcitabine 1250mg/m2 + NS 100ml MIV over 30min, every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | CR+PR with study therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability of the treatment |  | toxicity due to stdy drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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marginal zone lymphoma, gemcitabine