Gemcitabine for Marginal Zone Lymphoma

This study has been terminated.

(poor accrual and response less than expected on interim analysis)

Sponsor:

Collaborator:

Eli Lilly and Company

Information provided by (Responsible Party):

Cheolwon Suh, Asan Medical Center

ClinicalTrials.gov Identifier:

NCT00337259

First received: June 14, 2006

Last updated: February 13, 2016

Last verified: February 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

June 14, 2006

Last Updated Date

February 13, 2016

Start Date ^ICMJE

June 2006

Primary Completion Date

March 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

response rate [ Time Frame: CR+PR with study therapy ]

Original Primary Outcome Measures ^ICMJE

response rate
duration of response

Change History

Complete list of historical versions of study NCT00337259 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

safety and tolerability of the treatment
progression free survival
overall survival

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Gemcitabine for Marginal Zone Lymphoma

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Non-Hodgkin's Lymphoma
Marginal Zone Lymphoma

Intervention ^ICMJE

Drug: gemcitabine

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

Study Arms

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.

Intervention: Drug: gemcitabine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

March 2009

Primary Completion Date

March 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Korea, Republic of

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00337259

Other Study ID Numbers ^ICMJE

AMC 2006-60

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Cheolwon Suh, Asan Medical Center

Study Sponsor ^ICMJE

Asan Medical Center

Collaborators ^ICMJE

Eli Lilly and Company

Investigators ^ICMJE

Principal Investigator:

Cheolwon Suh, MD, PhD

Asan Medical Center

PRS Account

Asan Medical Center

Verification Date

February 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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