Yttrium-90 Ibritumomab Tiuxetan Plus High-Dose BEAM Followed By ASCT For Relapsed B-Cell Non-Hodgkin Lymphoma

Lymphoma Clinical Trial

Official title: A Phase II Study of Yttrium-90-Labeled Anti-CD20 Monoclonal Antibody in Combination With High-Dose Beam Followed by Autologous Stem Cell Transplantation for Poor Risk/Relapsed B-Cell Lymphoma

Status Completed

Clinical Trial Summary

This phase II clinical trial studies how well yttrium Y 90 ibritumomab tiuxetan, rituximab, and high-dose chemotherapy followed by peripheral blood stem cell transplant in treating patients with relapsed B-cell non-Hodgkin lymphoma. Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies can find tumor cells and carry tumor-killing substances to them without harming normal cells. Giving monoclonal antibody therapy, radioimmunotherapy (RIT), and high-dose combination chemotherapy before a peripheral blood stem cell transplant may be an effective treatment for non-Hodgkin lymphoma.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To estimate the 2-year progression free survival.

SECONDARY OBJECTIVES:

II. To estimate the 2-year overall survival.

III. To estimate the 2-year cumulative incidence of progression.

IV. To estimate time to hematopoietic recovery, using absolute neutrophil and platelet engraftment.

V. To estimate incidence of grade 3-4 toxicities by Bearman Scale, Day 0 to Day 100.

VI. To estimate the response rate (CR/PR).

VII. To estimate 100-day treatment related mortality.

VIII. To estimate incidence of myelodysplasia and therapy related acute myeloid leukemia (AML).

IX. To descriptively compare the outcomes of patients treated on this protocol to a comparable patient population treated with chemotherapy alone.

OUTLINE: RADIOIMMUNOTHERAPY: Patients receive yttrium Y 90 ibritumomab tiuxetan intravenously (IV) following rituximab IV on day -14.

HIGH-DOSE COMBINATION CHEMOTHERAPY: Patients receive carmustine IV on days -7 and -6; etoposide IV over 1 hour twice daily (BID) and cytarabine IV over 2 hours BID on days -5 to -2; and melphalan IV on day -1.

STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplant on day 0. Patients also receive rituximab on day 8*. NOTE: * Some patients may also receive rituximab on day -1. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically. ;

Related Conditions & MeSH terms

• Lymphoma

• NCT number: NCT00695409
• Study type: Interventional
• Source: City of Hope Medical Center
• Status: Completed
• Phase: Phase 2
• Start date: March 18, 2008
• Completion date: March 27, 2017