The Treatment of Hematologic Malignancies With Single or Double Umbilical Cord Blood Unit Transplantation Followed by Graft-versus-Host Prophylaxis With Tacrolimus and Mycophenolate Mofetil
OBJECTIVES:
Primary
- To determine the safety (as assessed by the day 100 non-relapse mortality) and
feasibility of single or double umbilical cord stem cell transplantation in patients
with hematological malignancies receiving graft-versus-host disease (GVHD) prophylaxis
comprising tacrolimus and mycophenolate mofetil (MMF).
Secondary
- To assess sustained donor engraftment, neutrophil recovery, platelet recovery,
incidence and severity of acute graft-versus-host disease (GVHD) and chronic GVHD,
relapse rate, 100-day all-cause mortality, overall survival, and immune reconstitution
after single or double umbilical cord stem cell transplantation in patients with
hematologic malignancies receiving graft-versus-host disease(GVHD) prophylaxis
comprising tacrolimus and mycophenolate mofetil (MMF).
OUTLINE:
- Conditioning: Patients receive myeloablative or reduced-intensity conditioning regimen
according to age and prior treatment.
- Myeloablative conditioning (pediatric patients): Patients undergo total-body
irradiation on days -7 to -4, and receive cyclophosphamide IV over 1 hour on days
-3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte
globulin IV over 4 hours on days -3 to -1.
- Myeloablative conditioning (adult patients 18-40 years old): Patients receive
fludarabine phosphate IV over 30 minutes on days -6 to -4, cyclophosphamide IV
over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to
-1.
- Reduced-intensity conditioning (patients over 40 and no more than 50 years old OR
deemed ineligible for above myeloablative conditioning regimen due to previous
treatment): Patients receive fludarabine phosphate IV over 30 minutes on days -6
to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body
irradiation on day -1.
- Umbilical cord blood transplantation (UCBT): All patients undergo single- or
double-unit umbilical cord blood transplantation (UCBT)on day 0.
- Graft-versus-host disease prophylaxis: Patients receive tacrolimus IV continuously or
orally twice daily on days -2 to 180 followed by a tapering and mycophenolate mofetil
IV or orally twice daily on days 0-100 followed by a tapering over the next 3 months.
Patients also receive filgrastim (G-CSF) IV or subcutaneously beginning on day 0* and
continuing until blood counts recover.
NOTE: *In adult patients receiving a reduced intensity transplant, G-CSF will be started
when the total white cell count falls below 2.5 x 109/L.
After completion of study treatment, patients are followed monthly for 1 year and then every
2-4 months thereafter.
Patient and UCB Unit Selection:
Interventional
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With 100-day Non-relapse Mortality
Evaluate the safety (as determined by the day 100 non-relapse mortality) and feasibility of single or double umbilical cord blood (UCB)stem cell transplant (SCT) in adult or pediatric patients with hematologic malignancies receiving graft-versus-host disease (GVHD) prophylaxis with tacrolimus and mycophenolate mofetil (MMF).
100 days
Yes
Brian Engelhardt, MD
Study Chair
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC BMT 0552
NCT00608517
September 2005
May 2011
Name | Location |
---|---|
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Veterans Affairs Medical Center - Nashville | Nashville, Tennessee 37212 |
Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville, Tennessee 37064 |
Vanderbilt-Ingram Cancer Center at Franklin | Nashville, Tennessee 37064 |