Allogeneic Bone Marrow Transplantation Using Closely Matched Related and Unrelated Donors
- Determine the survival of allogeneic bone marrow transplantation using closely matched
related and unrelated donors in patients with malignant or nonmalignant hematological
- Determine the incidence and severity of acute and chronic graft versus host disease
with this treatment regimen in these patients.
- Determine the relapse rates with this treatment regimen in those patients with
- Determine the incidence and severity of infectious complications associated with this
treatment regimen in these patients.
OUTLINE: Patients receive cyclophosphamide IV over 1 hour on days -6 and -5, total body
radiotherapy on days -3 through 0, and allogeneic bone marrow transplantation on day 0.
Patients with acute lymphocytic leukemia (ALL) receive intrathecal methotrexate at the
beginning of the study. If CNS involvement is documented, patients receive a second dose of
methotrexate 48 hours later followed by oral leucovorin calcium every 6 hours for 4 doses.
Patients with ALL and/or CNS involvement receive intrathecal methotrexate every other week
for 12 weeks after transplant.
Patients with prior CNS involvement receive radiotherapy for 2.5 weeks prior to transplant.
Patients with ALL receive total body radiotherapy for 5 consecutive days prior to
Patients are followed once a week for 3 months, and then monthly for 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 6 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
event free survival (EFS)
EFS determined by the Kaplan-Meier product limit method
five year post transplant
Teresa Field, MD, PhD
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government
|Moffitt Cancer Center||Tampa, Florida 33612|