Umbilical Cord Blood (UCB) Allogeneic Stem Cell Transplant for Hematologic Malignancies
1. To establish the day +180 overall survival after a myeloablative unrelated double unit
UCBT in a single institution setting.
1. To determine the rates of hematologic and immune reconstitution in patients with high
risk hematologic malignancies, who are undergoing myeloablative chemotherapy followed
by infusion of double unit UCBT.
2. To determine the contribution of each umbilical cord unit to immune reconstitution with
a focus on both initial (day +21 BM, and +28 PB) and sustained engraftment (day +100
BM; PB at +14, +21, +28, +35, +42, +60, +100, +180, +1 and 2 years).
3. To determine the probability of overall survival and disease free survival at one and
4. To describe the incidence of disease recurrence at one and two years in patients post
5. To describe the incidence of acute GVHD and chronic GVHD at 100 days and at one year,
6. To determine the incidence of day 100 and 180 treatment related mortality.
7. To determine the incidence of serious infectious complications in the first year after
8. To determine the incidence of donor-derived neutrophil and platelet recovery.
9. To determine the incidence of secondary lymphoproliferative diseases following
transplantation with umbilical cord blood.
PREPARATIVE REGIMEN: Patients receive oral busulfan every 6 hours on days -8 to -5,
cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV
on days -3 to -1.
TRANSPLANTATION: Patients undergo double-unit umbilical cord blood allogeneic stem cell
transplantation on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and
taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally every 8
hours on days -3 to 45. After completion of study treatment, patients are followed
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
On day +180
Brenda Cooper, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Institutional Review Board
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|