A Study Evaluating Escalating Doses of 90Y-DOTA-BC8 (Anti-CD45) Antibody Followed by Allogeneic Stem Cell Transplantation for High-Risk Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).
I. To estimate the maximum tolerated dose (MTD) of radiation delivered via 90Y-DOTA-BC8
(90Y-BC8) antibody (Ab) when combined with FLU and 2 Gy TBI as a preparative regimen for
patients aged >= 50 with advanced AML and high-risk MDS.
I. To determine disease response and duration of remission.
II. To determine the rates of engraftment and donor chimerism resulting from this combined
preparative regimen, and to correlate level of donor chimerism with estimated radiation
doses delivered to hematopoietic tissues via antibody.
PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on day -12 and FLU
intravenously (IV) over 30 minutes on days -4 to -2.
TRANSPLANTATION: Patients undergo TBI followed by allogeneic PBSC or bone marrow transplant
on day 0.
GRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive mycophenolate mofetil IV every 12
hours on days 0-27 (for patients with related donors) or every 8 hours on days 0-40 with
taper to day 96 (for patients with unrelated donors). Patients also receive cyclosporine
orally (PO) every 12 hours on days -3 to 56 (for patients with related donors) or 100 (for
patients with unrelated donors) with taper to day 180.
After completion of study treatment, patients are followed up at 6, 9, 12, 18, and 24
months, and then annually thereafter.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients who develop grades III/IV Bearman toxicity
Assessed according to Bearman scale for Regimen-Related Toxicities. Two-parameter logistic model will be fit to the data, thereby generating a dose-response curve based on the observed toxicity rate at the various dose levels visited.
Within the first 100 days following transplant
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
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