Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma
Completed · Phase 2
Conditions studied: Marginal Zone Lymphoma
In brief
Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).
Key facts
- Study ID
- NCT00453102
- Run by
- University of Miami
- People needed
- 18
- Starts
- 2006-02-01
- Expected to finish
- 2015-02-01
- Last updated by the study team
- 2016-01-01
Who can join
Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 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
You may not qualify if…
- 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
Where it is running
- University of Miami Sylvester Comprehensive Cancer Center - Miami — Miami, Florida, United States
Full record on ClinicalTrials.gov
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