Gemcitabine for Marginal Zone Lymphoma

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00337259
• Other study ID #: AMC 2006-60
• Status: Terminated
• Phase: Phase 2
• First received: June 14, 2006
• Last updated: February 13, 2016
• Start date: June 2006
• Est. completion date: March 2009

Study information

• Verified date: February 2016
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Non-Hodgkin
• Marginal Zone Lymphoma
• Non-Hodgkin's Lymphoma

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Eli Lilly and Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate		CR+PR with study therapy	No
Secondary	safety and tolerability of the treatment		toxicity due to stdy drug	Yes