A Phase II Study of Reduced Intensity Double Umbilical Cord Blood Transplantation Using Fludarabine, Melphalan, and Low Dose Total Body Radiation
Subjects will receive their transplants as in-patients.
- IV-Catheter
- one or two IV catheters will be placed on the day of hospital admission
- Conditioning
- Fludarabine IV six days before transplant (days -7, -6, -5. -4, -3, -2)
- Melphalan IV (day -1)
- Total body radiation on day 0 (same day as transplant)
- Immunosuppressive Therapy
- Tacrolimus and sirolimus beginning day -3, daily for 6-9 months post-transplant.
Given IV as in-patient, orally as out-patient
- Infusion of Cord Blood units
- 2 cord blood units IV on Day 0 Routine post-transplant supportive care will be
provided
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
One year significant viral infection rate
To determine the one year significant viral infection rate (viral infections requiring medical intervention) after double umbilical cord blood transplant using a novel conditioning regimen of fludarabine/melphalan/low dose total body radiation
2.5 years
Yes
Karen Ballen, MD
Principal Investigator
Massachusetts General Hospital
United States: Institutional Review Board
11-085
NCT01408563
September 2011
January 2015
Name | Location |
---|---|
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |