A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplant for B-Cell Non-Hodgkin Lymphoma Using Zevalin, Fludarabine and Melphalan
OBJECTIVES:
- To evaluate the safety and efficacy of a preparative regimen of Yttrium-90 (90^Y)-
Labeled Anti-CD20 Monoclonal Antibody (MAb) (yttrium Y 90 ibritumomab tiuxetan) in
combination with Fludarabine (fludarabine phosphate) and Melphalan followed by
Allogeneic Hematopoietic Stem Cell Transplant (APBSCT) for treatment of patients with
B-Cell Low-Grade Non-Hodgkin Lymphoma (LG NHL), Intermediate-Grade Non-Hodgkin Lymphoma
(IG NHL) and Mantle Cell Lymphoma (MCL). II. To evaluate the short- and long-term
complications of this new preparative regimen, including rates of engraftment, Acute
and Chronic Graft-Versus-Host-Disease (GVHD) and infectious complications. III. To
estimate the disease response rate, disease relapse (progression) rate, and non-relapse
mortality rate of this treatment strategy. IV. To perform exploratory studies that seek
to measure/characterize the expression of costimulatory molecules and impact of these
molecules on the natural killer (NK) and T cells of lymphoma patients pre- post-
allogeneic stem cell transplant (ASCT).
OUTLINE:
- REDUCED-INTENSITY CONDITIONING: Patients receive rituximab IV followed by indium In-111
ibritumomab tiuxetan IV over 10 minutes on day -21 and rituximab IV followed by yttrium
Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive
fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4. STEM CELL
TRANSPLANTATION: Patients undergo APBSCT on day 0. GVHD PROPHYLAXIS: Patients receive
tacrolimus IV or orally (PO) and sirolimus PO beginning on day -3 and continuing for up
to 6 months with taper. After completion of study treatment, patients are followed up
every 3 months for 1 year and then every 6 months for up to 5 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Relapse/progression rate
Confidence intervals will be established by calculating the exact 95% confidence limits for a binomial parameter. The product-limit method of Kaplan and Meier will be utilized.
At 2 years
No
Auayporn P. Nademanee, MD
Study Chair
City of Hope Medical Center
United States: Federal Government
05149
NCT00577278
January 2007
Name | Location |
---|---|
City of Hope Medical Center | Duarte, California 91010 |