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

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

Detailed Description
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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.

Official Title
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Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma

Conditions
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Marginal Zone Lymphoma

Intervention / Treatment
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* Drug: Rituximab
* Drug: Ibritumomab Tiuxetan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zevalin + Rituximab<br>Ibritumomab Tiuxetan (Zevalin) + Rituximab | Drug: Rituximab<br>* IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³<br>* Other names: Chimeric anti-CD20 monoclonal antibody;Drug: Ibritumomab Tiuxetan<br>* IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9: 0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³<br>* Other names: Zevalin;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Marginal Zone Lymphoma, Non-gastric extranodal Marginal Zone Lymphoma, Splenic Marginal Zone Lymphoma, Nodal Marginal Zone Lymphoma, Gastric Marginal Zone Lymphoma, MZL, Non-gastric extranodal MZL, Splenic MZL, Nodal MZL, Gastric MZL