The purpose of this research study is to determine the safety and efficacy of a reduced intensity conditioning regimen during a double umbilical cord blood unit transplant with one of the cord blood units modulated with ProHema.
The purpose of this research study is to determine the safety and efficacy of a reduced intensity conditioning regimen during a double umbilical cord blood unit transplant with one of the cord blood units modulated with ProHema. -As part of this research study cord units will be modulated in the laboratory with ProHema before it is given to the participant. Two different treatment groups will be tested. Group 1: will have the second cord blood unit modulated with ProHema; Group 2: will have the first cord blood unit modulated with ProHema.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Determine the safety of ProHema modulated umbilical cord blood units when used for transplantation in a reduced intensity, sequential umbilical cord blood transplantation model.
Time frame: 2 years
Time to engraftment of umbilical cord blood units
Time frame: 2 years
Fractional chimerism of transplanted cord blood units
Time frame: 2 years
Rates of acute and chronic GVHD
Time frame: 2 years
30- and 100-day treatment related mortality
Time frame: 2 years
Measures of immune reconstitution and relapse-free and overall survival at 1 and 2 years after transplantation
Time frame: 2 years
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GVHD Prophylaxis: Target range 3-12 ng/ml
GVHD Prophylaxis: Target range 5-10 ng/ml