The purpose of this study is to see if conditioning regimens that include personalized rabbit ATG (P-rATG) help the immune system recover sooner and decrease the chances of transplant-related side effects. Participants in this study will be children and adults who have acute leukemia or myelodysplastic syndrome (MDS), and will receive a standard conditioning regimen to prepare the body for an allogeneic hematopoietic cell transplant (allo-HCT). The conditioning regimen will include r-ATG, one of two combinations of chemotherapy, and possibly total body irradiation (TBI).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
P-rATG days (always starting on Day -12 to -10)
(1375 - 1500cGy\*) Day -9 to -6 \*TBI dose in 125cGy fractions (with lung shielding) and total dose to be determined by treating physician/radiation oncology and is based off age, stage of disease, and anesthesia requirements.
(5mg/kg/day x 2 day) Day -5 to -4
(60mg/kg/day x 2 days) Day -3 to -2
Day +7
Day -9 to -7 doses 2-3 to be adjusted per PK for target cumulative exposure of 65 mg\*h/L
(70mg/m2/day x 2 days) Day -6 to -5
(25mg/m2/day x 5 days) Day -6 to -2
Memorial Sloan Kettering Cancer Center
New York, New York, United States
proportion of patients who achieve CD4+IR
is defined at CD4+ \> 50u/L at two consecutive measures within 100 days post allo-HCT.
Time frame: within 100 days of HCT
Overall Survival (OS)
The duration of time between HCT and death due to any cause.
Time frame: 2 years
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