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Clinical Trial · NCT00453102
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma
Overview
Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).
Sponsor
University of Cambridge
Phase
Phase 2
Contacts
Izidore S. Lossos, MD (STUDY_CHAIR)
ClinicalTrials.gov
NCT00453102Drug / Compound
Ibritumomab tiuxetan
Isotope(s):
YTTRIUM-90
Radioisotope: Y-90
Theranostic Role: Therapeutic Agent, SPECT Imaging & PET Imaging
T1/2 (Half-Life): 2.7 Days
Decay Mode: BETA
Energy: max 2.2 MeV
Range: In Tissue: Avg 2.5 mm, Max 11 mm; In Air: 35 feet
Decay Daughters: Zr90 (Stable)
Status: FDA Approvals: SIR-SPHERES® (2000), THERASPHERES® (2021)
Target(s):
- cd20
Ligand Class: Antibodies
Chelator: Tiuxetan
Eligibility
Inclusion
- All stages are eligible
- Measurable and evaluable disease
- Life expectancy of at least 6 months
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (Appendix B)
Exclusion
- Known history of HIV infection
- Woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection.
- Prior chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy before beginning study treatment.
- Physical or mental condition that makes patient unable to complete specified follow-up assessments
- Pregnant or lactating (pregnancy test is required for all female patients of childbearing potential)
- Platelet count \< 100,000 cells/mm³
- Neutrophil count \< 1,500 cells/mm³
- ≥ 25% lymphoma bone marrow involvement
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