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

Phase 2

Completed

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Zevalin + Rituximab	Rituximab	Ibritumomab Tiuxetan (Zevalin) + Rituximab
Zevalin + Rituximab	Ibritumomab Tiuxetan	Ibritumomab Tiuxetan (Zevalin) + Rituximab

Primary Outcome Measures

Name	Time	Method
Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.	12 weeks post-therapy	The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy.

Secondary Outcome Measures

Name	Time	Method
Rate of Progression-Free Survival	End of study.	The time from the start of protocol therapy until the first documented or confirmed disease progression, or death related to study disease, whichever is earlier.
5-Year Rate of Progression-Free Survival (5-Year PFS)	5 Years	Percentage of participants still alive without disease progression five years after the date of protocol therapy initiation.
Overall Survival (OS) Rate	End of Study	The time from the date of initiation of study treatment until date of death from any cause for all participants.
5 Year Rate of Overall Survival (5-Year OS)	5 Years	Percentage of participants still alive five years after the date of protocol therapy initiation.
Number of Participants With Unacceptable Toxicity.	Up to 12 weeks post-therapy	Number of participants with treatment-related (possible, probable, or definite) grade 3 or higher non-hematologic adverse events.