Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Treatments: Antibodies, Monoclonal; Rituximab

Criteria

Inclusion Criteria:

• ≥ 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 Criteria:

• 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