Gemcitabine for Marginal Zone Lymphoma

NCT ID: NCT00337259

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2009-03-31

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.

Conditions

Non-Hodgkin's Lymphoma; Marginal Zone Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

gemcitabine

Intervention Type: DRUG

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

Interventions

gemcitabine

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

Intervention Type: DRUG

Eligibility 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 cervix
• Serious comorbid diseases
• Pregnancy or breast feeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Cheolwon Suh

ASCT team

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheolwon Suh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

AMC 2006-60

Identifier Type: -

Identifier Source: org_study_id