The primary objective of this study is to assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific antibodies and in those with active disease.
Primary Objective \- To assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific anti-HLA antibodies and in those with active disease Secondary Objectives * To determine the long term fate of the haplo transplant and the cord blood transplant in this setting. * To describe the incidence and severity of acute and chronic GVHD.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.
Fludarabine is given through the vein daily for 5 days.
ATG is given every other day for 4 days.
University of Chicago
Chicago, Illinois, United States
Cord Blood Engraftment by Day 100
Percent of subjects with cord blood engraftment on or before day 100. Detectable cord blood engraftment should be present by day 100 in at least 50% of patients. As of 44 days post-transplant, only haploidentical donor chimerism achieved in the one patient enrolled in the Fludarabine, melphalan, and ATG arm. There were no cord cells detected for this patient.
Time frame: 100 days
Survival at Day 100
Percent of subjects who are alive 100 days after the stem cell infusion
Time frame: 100 days
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Busulfan is given daily for 4 days.
TBI is given twice on the last day.