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

University of Miami

Status and phase: Completed; Phase 2

Conditions: Marginal Zone Lymphoma

Treatments: Drug: Ibritumomab Tiuxetan; Drug: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00453102

SCCC-2005133 (Other Identifier)

20060078

WIRB-20060249 (Other Identifier)

Details and patient eligibility

About

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

Full 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 with mucosa-associated lymphoid tissue (MALT) gastric lymphoma.

Enrollment: 18 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Zevalin + Rituximab

Experimental group

Description:

Ibritumomab Tiuxetan (Zevalin) + Rituximab

Treatment:

Drug: Rituximab

Drug: Ibritumomab Tiuxetan