Gemcitabine for Marginal Zone Lymphoma

Sponsor

Asan Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT00337259

Collaborator

Eli Lilly and Company (Industry)

Enrollment

Location

Arm

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma Marginal Zone Lymphoma	Drug: gemcitabine	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: gemcitabine D1 and 8, Gemcitabine 1250mg/m2 + NS 100ml MIV over 30min, every 3 weeks

Arm

Intervention/Treatment

Experimental: 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.

Drug: gemcitabine

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

Outcome Measures

Primary Outcome Measures

response rate [CR+PR with study therapy]

Secondary Outcome Measures

safety and tolerability of the treatment [toxicity due to stdy drug]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of	138-736

Sponsors and Collaborators

Asan Medical Center
Eli Lilly and Company

Investigators

Principal Investigator: Cheolwon Suh, MD, PhD, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cheolwon Suh, ASCT team, Asan Medical Center

ClinicalTrials.gov Identifier:

NCT00337259

Other Study ID Numbers:

AMC 2006-60

First Posted:

Jun 15, 2006

Last Update Posted:

Feb 17, 2016

Last Verified:

Feb 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Cheolwon Suh, ASCT team, Asan Medical Center

marginal zone lymphoma

gemcitabine

Additional relevant MeSH terms:

Lymphoma

Lymphoma, B-Cell, Marginal Zone

Gemcitabine

Study Results

No Results Posted as of Feb 17, 2016