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

June 14, 2006
February 13, 2016
June 2006
March 2009   (final data collection date for primary outcome measure)
response rate [ Time Frame: CR+PR with study therapy ] [ Designated as safety issue: No ]
  • response rate
  • duration of response
Complete list of historical versions of study NCT00337259 on ClinicalTrials.gov Archive Site
safety and tolerability of the treatment [ Time Frame: toxicity due to stdy drug ] [ Designated as safety issue: Yes ]
  • safety and tolerability of the treatment
  • progression free survival
  • overall survival
Not Provided
Not Provided
 
Gemcitabine for Marginal Zone Lymphoma
Phase II Study of Gemcitabine in Patients With Advanced Stage Marginal Zone B-cell Lymphoma
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-Hodgkin's Lymphoma
  • Marginal Zone Lymphoma
Drug: gemcitabine
D1 and 8, Gemcitabine 1250mg/m2 + NS 100ml MIV over 30min, every 3 weeks
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
43
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00337259
AMC 2006-60
Yes
No
Not Provided
Cheolwon Suh, Asan Medical Center
Asan Medical Center
Eli Lilly and Company
Principal Investigator: Cheolwon Suh, MD, PhD Asan Medical Center
Asan Medical Center
February 2016

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