Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma
RATIONALE: A variety of single agent and combination chemotherapy regimens have been examined in MALT lymphomas, including oral alkylating agents, purine analogs, rituximab and combination regimens (e.g. chlorambucil, mitoxantrone, and prednisone). While these treatments lead to high rates of disease control, the majority of patients relapse and progress over time and disseminated MZLs are considered incurable. Radiotherapy in localized MALT and nodal MZL frequently results in long-term local control and prolonged progression-free survival (PFS). However, distant relapses are observed in 10% to 15% of patients with extranodal MALT lymphomas treated with radiotherapy, suggesting the presence of occult dissemination already at the time of initial diagnosis.
Radioimmunotherapy with 90yttrium (90Y) ibritumomab tiuxetan (Zevalin) is currently approved for treatment of patients with relapsed or refractory low grade or follicular NHLs and previously untreated follicular lymphoma who achieve a partial or complete response to first-line chemotherapy. Considering the excellent local control of MZLs with radiotherapy, targeted delivery of radiation by radioimmunotherapy may be the optimal approach for patients with untreated disseminated MZL and even for patients with localized MZL in whom occult distance disease may be present
PURPOSE: Examine efficacy of yttrium Y 90 ibritumomab tiuxetan in patients with untreated newly diagnosed marginal zone lymphoma.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma|
- Clinical response rate (complete response [CR], unconfirmed CR, and partial response) [ Time Frame: 6 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2006|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
|Experimental: Zevalin + Rituximab||
IV Infusion of 250mg/m² of Rituximab Within 4 hours 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/mm³Drug: Ibritumomab Tiuxetan
IV injection of In-111 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
Other Name: Zevalin
- Assess the clinical response rate (complete response [CR], unconfirmed CR, and partial response) in patients with previously untreated marginal zone lymphoma treated with 90Y ibritumomab tiuxetan and rituximab.
- Determine progression-free survival, in terms of time to relapse or progression, of patients treated with this regimen.
- Determine overall survival of patients treated with this regimen.
- Assess local disease control in these patients
- Evaluate the safety and tolerability of this regimen in these patients.
OUTLINE: Patients receive rituximab IV on day 1. Patients receive rituximab IV follow by 90Y ibritumomab tiuxetan IV push on day 7, 8, or 9.
After the completion of study treatment, patients will be seen in clinic every 2 weeks for the first 12 weeks. Then patients will be followed every 3 months for 2 years and then every 6 months for next 3 years or until disease progression.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453102
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: University of Miami Sylvester Comprehensive Cancer Center Clin 866-574-5124 Sylvester@emergingmed.com|
|Study Chair:||Izidore S. Lossos, MD||University of Miami Sylvester Comprehensive Cancer Center|