Nonmyeloablative Hematopoietic Cell Transplantation (HCT) for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Phase II Trial of Peripheral Blood Stem Cells (PBSC) as the Donor Source
PRIMARY OBJECTIVES:
I. To demonstrate that use of PBSC in place of marrow as the source of lymphocytes and stem
cells for nonmyeloablative transplants from related, haploidentical donors will not result
in unacceptable rates of high-grade acute or chronic GvHD, nonrelapse mortality (NRM) or
relapse compared to historical data on nonmyeloablative transplants from unrelated donors.
SECONDARY OBJECTIVES:
I. Estimates of the rates of neutrophil and platelet recovery, number of red blood cell
(RBC) and platelet transfusions, incidences of graft failure, transplant-related toxicities,
disease-free survival and overall survival.
OUTLINE:
Patients receive fludarabine intravenously (IV) over 30-60 minutes daily on days -6 through
-2 and cyclophosphamide IV over 1-2 hours on days -6, -5, and 3-4. Patients undergo
total-body irradiation on day -1. Patients undergo donor peripheral blood stem cell
transplant on day 0. Patients then receive tacrolimus IV once daily or orally (PO) twice
daily on days 5-180 (may be continued if active GvHD is present), mycophenolate mofetil IV
or PO thrice daily (TID) on days 5-35 (may be continued if GvHD present), and filgrastim IV
or subcutaneously (SC) beginning on day 5 until the absolute neutrophil count (ANC) is >=
1,000/mm^3 for three consecutive days.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of grades III/IV acute GvHD
Grading determined by organ system stages. Grade III/IV acute GVHD is defined as skin: stage IV, liver: stages II-IV, and/or gastrointestinal tract: stages II-IV.
At day 84
No
Paul O'Donnell
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
2372.00
NCT01028716
February 2010
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |