A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Patients With High Risk Hematologic Malignancies
- Determine the rates of hematologic and immune reconstitution in patients with high risk
hematologic malignancies who are undergoing high dose chemoradiotherapy followed by
unrelated umbilical cord blood (UCB) transplantation.
- Determine the incidence of graft-versus-host-disease in this setting.
- Describe the incidence of recurrent disease in these patients post UCB transplant.
- Describe the incidence of serious infections and secondary lymphoproliferative diseases
following transplantation with UCB in these patients.
- Determine specifically whether larger recipients can be durably engrafted with
unrelated UCB, and determine whether nucleated cell or progenitor cell content of the
graft is predictive of hematological engraftment.
OUTLINE: Patients may undergo a back-up peripheral blood stem cell collection prior to
Patients receive 9 fractions of total body irradiation (TBI) on days -9 to -5 followed by
melphalan IV for three days on days -4 to -2 and antithymocyte globulin IV or
methylprednisolone IV for three days on days -3 to -1. On day 0, patients receive umbilical
cord blood infusion. If TBI is not tolerated, busulfan is substituted and administered
orally every 6 hours for 4 days on days -8 to -5. Cyclosporine and methylprednisolone begin
on day -2 and continue for 6 months.
Patients are followed at least monthly for 1 year, then every 6 months for the second year,
and then annually thereafter.
PROJECTED ACCRUAL: There will be a maximum of 48 patients accrued into this study over 4
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
rates of durable engraftment in patients
The primary study end point will be hematologic engraftment. Engraftment is defined as achieving ANC larger than or equal to 500 ul/mm3 of donor origin for three consecutive measurements on different days by day +42.
Brenda W. Cooper, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Federal Government
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|