Back to resultsGemcitabine for Marginal Zone Lymphoma
Primary Purpose
Non-Hodgkin's Lymphoma, Marginal Zone Lymphoma
Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring marginal zone lymphoma, gemcitabine
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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gemcitabine
Arm Description
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.
Outcomes
Primary Outcome Measures
response rate
Secondary Outcome Measures
safety and tolerability of the treatment
Full Information
NCT ID
NCT00337259
First Posted
June 14, 2006
Last Updated
February 13, 2016
Sponsor
Asan Medical Center
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00337259
Brief Title
Gemcitabine for Marginal Zone Lymphoma
Official Title
Phase II Study of Gemcitabine in Patients With Advanced Stage Marginal Zone B-cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
poor accrual and response less than expected on interim analysis
Study Start Date
June 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma, Marginal Zone Lymphoma
Keywords
marginal zone lymphoma, gemcitabine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gemcitabine
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
gemcitabine
Intervention Description
D1 and 8, Gemcitabine 1250mg/m2 + NS 100ml MIV over 30min, every 3 weeks
Primary Outcome Measure Information:
Title
response rate
Time Frame
CR+PR with study therapy
Secondary Outcome Measure Information:
Title
safety and tolerability of the treatment
Time Frame
toxicity due to stdy drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheolwon Suh, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gemcitabine for Marginal Zone Lymphoma
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