Status:
COMPLETED
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma
Lead Sponsor:
University of Miami
Conditions:
Marginal Zone Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).
Detailed Description
This phase II study will assess the clinical response rate to Ibritumomab Tiuxetan in patients with untreated nodal, splenic and non-gastric extranodal MZL as well as in antibiotic resistant patients ...
Eligibility Criteria
Inclusion
- ≥ 18 years old with previously untreated, histologically confirmed Marginal Zone Lymphoma (non-gastric extranodal MZL, splenic MZL and nodal MZL) or gastric MZL that did not respond to antibiotic therapy given up to 6 months prior to enrollment, but not less than 2 months)
- Measurable and evaluable disease
- All stages are eligible
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (Appendix B)
- Willing and able to provide written informed consent
- Women of childbearing potential must have a negative pregnancy test at study entry and must agree to use effective contraception while on treatment and for 6 months after treatment
- Life expectancy of at least 6 months
Exclusion
- Prior chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy before beginning study treatment.
- ≥ 25% lymphoma bone marrow involvement
- Platelet count \< 100,000 cells/mm³
- Neutrophil count \< 1,500 cells/mm³
- Known history of HIV infection
- Pregnant or lactating (pregnancy test is required for all female patients of childbearing potential)
- Woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection.
- Physical or mental condition that makes patient unable to complete specified follow-up assessments
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00453102
Start Date
February 1 2006
End Date
February 1 2015
Last Update
January 1 2016
Active Locations (1)
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1
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136