A Phase I Open-Label, Safety Study of Haploidentical Bone Marrow Transplantation (BMT) After Ex Vivo Treatment of Bone Marrow With Anti-B7.1 and Anti-B7.2 Antibodies
OBJECTIVES: I. Determine if patients with refractory, high risk hematologic malignancies or
bone marrow failure who receive HLA haploidentical bone marrow treated with anti-B7 antibody
have normal engraftment. II. Determine if these patients are free of hyperacute graft versus
host disease (GVHD), defined as grade D GVHD in the first 10 posttransplant days, when
treated with this regimen. III. Determine if these patients have an acceptable incidence of
life threatening grade D GHVD in the first 50 posttransplant days following this treatment
regimen. IV. Determine the safety and tolerability of this treatment regimen in this patient
OUTLINE: This is a multicenter study. Patients undergo leukapheresis to collect white blood
cells which are incubated with donor bone marrow cells in the presence of anti-B7.1 and
anti-B7.2 antibodies for 36 hours. Patients receive total body irradiation twice daily on
days -6 to -3, cyclophosphamide IV daily on days -2 and -1, and methylprednisolone IV every
12 hours for a total of 4 doses on days -2 to 0. Patients are infused with the treated donor
bone marrow on day 0. Patients then receive methotrexate IV on days 1, 3, 6, and 11 and
leucovorin calcium IV 24 hours after each dose of methotrexate every 6 hours for 3-8 doses
each time. Patients also receive cyclosporine IV or orally twice daily on days -2 to 100.
Patients are followed every 2 months for 1 year.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Primary Purpose: Supportive Care
Eva Guinan, MD
Dana-Farber Cancer Institute
United States: Federal Government
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|