Study Stopped
poor accrual and response less than expected on interim analysis
Gemcitabine for Marginal Zone Lymphoma
Phase II Study of Gemcitabine in Patients With Advanced Stage Marginal Zone B-cell Lymphoma
1 other identifier
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 14, 2006
CompletedFirst Posted
Study publicly available on registry
June 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFebruary 17, 2016
February 1, 2016
2.8 years
June 14, 2006
February 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
response rate
CR+PR with study therapy
Secondary Outcomes (1)
safety and tolerability of the treatment
toxicity due to stdy drug
Study Arms (1)
Gemcitabine
EXPERIMENTAL* 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.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed marginal zone B-cell lymphoma
- Performance status (ECOG) ≤3
- Age ≥ 18
- At least one or more bidimensionally measurable lesion(s):
- cm by conventional CT
- 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
You may not qualify if:
- Any other malignancies within the past 5 years except skin basal cell ca or CIS of cervix
- Serious comorbid diseases
- Pregnancy or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asan Medical Centerlead
- Eli Lilly and Companycollaborator
Study Sites (1)
Asan Medical Center
Seoul, 138-736, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheolwon Suh, MD, PhD
Asan Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- ASCT team
Study Record Dates
First Submitted
June 14, 2006
First Posted
June 15, 2006
Study Start
June 1, 2006
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
February 17, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share