Ibritumomab Tiuxetan (Zevalin)+ Rituximab Maintenance

University of Wisconsin (UW)

Status and phase: Terminated; Phase 2

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: Ibritumomab Tiuxetan (Zevalin) + Rituximab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00582166

NCI-2011-00579 (Registry Identifier)

HO04405

A534260 (Other Identifier)

SMPH\MEDICINE\HEM-ONC (Other Identifier)

Details and patient eligibility

About

Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression

Full description

The objective of this study is to estimate the median progression-free survival for patients receiving this regimen, along with the rate of complete response at 6 months, toxicities associated with this regimen, and laboratory correlates. Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with biopsy-proven non-hodgkins lymphoma of follicular grade 1, 2, or 3
• Meeting FLIPI criteria for intermediate or high risk.
• No prior chemotherapy, radiotherapy or immunotherapy for lymphoma;
• Patients may not have known HIV infection, and must not be Hepatitis B Surface Antigen positive.

Exclusion criteria

• May not be pregnant or breastfeeding, have documented CNS (Central Nervous System) disease, G-CSF (Granulocyte Colony Stimulating Facto) or GM-CSF (Granulocyte/Macrophage Colony Stimulating Factor) within 2 weeks prior

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

Ibritumomab Tiuxetan (Zevalin) with Rituximab maintenance

Experimental group

Treatment:

Drug: Ibritumomab Tiuxetan (Zevalin) + Rituximab