Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase II Trial Evaluating the Safety and Efficacy of Non-myeloablative 90Y-Ibritumomab Tiuxetan (Anti-CD20) Antibody With Fludarabine, Low-Dose Total Body Irradiation (TBI) and HLA Matched Allogeneic Transplantation for Relapsed B-cell Lymphoma
Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can block find cancer cells and either kill them or carry cancer-killing substances to them without harming normal cells. Giving monoclonal antibodies, low doses of chemotherapy, such as fludarabine phosphate, and low dose total-body radiation therapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells and also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine or mycophenolate mofetil after the transplant may stop this from happening
PRIMARY OBJECTIVES:
I. To assess the feasibility, safety, and potential efficacy of treating patients with B-Cell
non-Hodgkin lymphoma (NHL) with 90Y-ibritumomab tiuxetan, combined with HLA-matched related
or unrelated donor hematopoietic cell transplantation.
OUTLINE: Patients receive rituximab intravenously (IV) followed by, no more than 4 hours
later, indium In 111 ibritumomab tiuxetan (for imaging) IV over 10 minutes on day -21.
Patients undergo gamma camera imaging on day -19. Patients receive rituximab IV followed by,
no more than 4 hours later, yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14.
Patients also receive fludarabine phosphate IV over 30-60 minutes on days -7 to -5 and
undergo low-dose total-body irradiation (TBI) on day 0. After TBI, patients undergo
allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0. Patients who undergo
PBSCT from a related donor receive oral cyclosporine twice daily on days -3 to 56 followed by
a taper to day 180 in the absence of graft-versus-host disease (GVHD). These patients also
receive oral mycophenolate mofetil twice daily on days 0 to 27. Patients who undergo PBSCT
from an unrelated donor receive oral cyclosporine twice daily on days -3 to 100 followed by a
taper over 11 weeks in the absence of GVHD. These patients also receive oral mycophenolate
mofetil three times daily on days 0 to 40 followed by a taper to day 96.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months, and
then annually thereafter.
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|---|---|---|---|
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