A Pilot Study of Using Filgrastim-Primed Bone Marrow in Human Leukocyte Antigen (HLA) Matched Related Donor Allogenetic Bone Marrow Transplantation for Patients With Hematologic Malignancies and Non-Malignancies
OBJECTIVES:
Primary
- Determine whether granulocyte engraftment can be achieved by day 30 in patients with
hematologic disorders undergoing HLA-matched, related-donor, allogeneic bone marrow
transplantation using filgrastim (G-CSF)-primed bone marrow.
- Determine the incidence of grade II or greater acute graft-versus-host disease (GVHD)
in patients treated with this regimen and post-transplantation immunosuppression with
cyclosporine and methotrexate.
Secondary
- Determine whether platelet and red blood cell engraftment can be achieved in patients
treated with this regimen.
- Determine the incidence of limited and extensive chronic GVHD in patients treated with
this regimen.
- Determine the event-free survival of patients treated with this regimen.
- Determine the post-transplant immune reconstitution in patients treated with this
regimen.
OUTLINE: This is a pilot study.
- Mobilization: Donors receive filgrastim (G-CSF) subcutaneously (SC) daily on days -3 to
-1 followed by bone marrow collection.
- Conditioning regimen: Patients receive 1 of the following conditioning regimens
according to their primary disease:
- Total-body irradiation and high-dose chemotherapy comprising etoposide and
cyclophosphamide
- High-dose chemotherapy comprising busulfan and cyclophosphamide
- Bone marrow transplantation: Patients receive G-CSF-primed allogeneic bone marrow on
day 0. Patients then receive G-CSF SC beginning on day 5.
- Graft-versus-host disease prophylaxis: Patients receive cyclosporine beginning on day
-1 and methotrexate on days 1, 3, and 6.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Eneida Nemecek, MD
Principal Investigator
OHSU Knight Cancer Institute
United States: Federal Government
CDR0000445188
NCT00253552
May 2004
May 2006
Name | Location |
---|---|
OHSU Knight Cancer Institute | Portland, Oregon 97239 |