Transplantation of Umbilical Cord Blood for Myeloid Leukemia Patients Not in CR With Cyclophosphamide/Fludarabine/Total Body Irradiation Myeloablative Preparative Regimen and UCB NK Cells
- Determine the incidence of 6-month disease free survival. The primary laboratory
objective is the measure of in vivo expansion of umbilical cord blood (UCB) derived
natural killer cells (NK) after a fully ablative preparative regimen.
- Determine the incidence of transplant-related mortality at 6 months after NK UCB +
- Evaluate the pattern of chimerism after NK UCB + double UCBT
- Determine the incidence of neutrophil engraftment at day 42 after NK UCB + double
umbilical cord blood transplantation (UCBT)
- Determine the incidence of platelet engraftment at 6 months after NK UCB + double UCBT
- Determine the incidence of acute graft-versus-host disease (GVHD) grade II-IV and grade
III-IV at day 100 after NK UCB + double UCBT
- Determine the incidence of chronic GVHD at 1 year after NK UCB + double UCBT
- Determine the disease-free survival at 1 after NK UCB + double UCBT
- Determine the incidence of relapse at 1 after NK UCB + double UCBT
OUTLINE: This is a single arm, nonrandomized, open-label study.
- Myeloablative conditioning regimen: Patients receive fludarabine intravenously (IV)
over 1 hour on days -18 to -16 and cyclophosphamide intravenously (IV) on days -18 and
-17. Patients undergo total-body irradiation twice daily on days -16 to -13.
- Haploidentical umbilical cord blood (UCB) natural killer (NK) cell therapy and
aldesleukin: Patients undergo haploidentical UCB-enriched NK cell (CD3- depleted)
infusion on day -13. Patients then receive aldesleukin subcutaneously on days -13, -11,
-9, -7, -5, and -3. Some patients may also receive methylprednisolone IV on days -1 and
- UCB transplantation (UCBT): Patients undergo a single or double UCBT on day 0.
Beginning on day 1, patients receive filgrastim (G-CSF) IV once daily until blood
- Graft-vs-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV over 2 hours
2-3 times daily beginning on day -1 and continuing until day 100, followed by a taper
until day 180. Patients also receive mycophenolate mofetil IV or orally 2-3 times daily
beginning on day -1 and continuing until day 30 (or 7 days after engraftment) in the
absence of acute GVHD.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months
Number of patients who were alive and free of disease (malignancy) at 6 months after transplant.
6 Months Post Transplant
Jeffrey Miller, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|