A Pilot Study of Double Cord Blood Stem Cell Transplantation in Patients With Hematologic Malignancies
- Determine the efficacy of double umbilical cord blood stem cell transplantation using a
conditioning regimen comprising lower doses of busulfan and fludarabine phosphate and
low-dose total body irradiation, in terms of stem cell engraftment at 60 days post
transplantation, in patients with hematologic cancer or other diseases.
- Determine the merits of conducting a larger, comparative study of this regimen.
- Determine mortality within 100 days of transplantation in these patients.
OUTLINE: This is a pilot study.
- Reduced-intensity conditioning regimen: Patients receive busulfan IV over 3 hours on
days -9 to -8 and fludarabine phosphate IV on days -7 to -3. Patients then undergo
low-dose total body irradiation on day 0.
- Graft-versus-host disease prophylaxis: Patients receive tacrolimus IV twice daily and
mycophenolate orally or IV three times daily beginning on day -3.
- CNS prophylaxis and/or treatment: Patients with a history of CNS involvement receive
prophylactic cytarabine (Ara-C) intrathecally (IT) prior to transplant. Patients also
undergo lumbar puncture (LP) to test for active CNS disease. Patients with
cerebrospinal fluid positive for leukemia receive Ara-C IT every 2-3 days until a
repeat LP shows no remaining leukemic cells. Three days after the last LP and after one
final dose of Ara-C, patients begin the conditioning regimen.
- Double umbilical cord blood (UCB) donor stem cell transplantation (SCT): Patients
undergo double UCB donor SCT on day 0.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
60 days post transplantation
Voravit Ratanatharathorn, MD
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|