Gemcitabine for Marginal Zone Lymphoma

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00337259

Enrollment

Registered

2006-06-15

Start date

2006-06-30

Completion date

2009-03-31

Last updated

2016-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Marginal Zone Lymphoma, Non-Hodgkin's Lymphoma

Keywords

marginal zone lymphoma, gemcitabine

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.

Interventions

DRUGgemcitabine

D1 and 8, Gemcitabine 1250mg/m2 + NS 100ml MIV over 30min, every 3 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
response rate	CR+PR with study therapy

Secondary

Measure	Time frame
safety and tolerability of the treatment	toxicity due to stdy drug

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026