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A Modified Dose of Rabbit Anti-thymocyte Globulin (rATG) in Children and Adults Receiving Treatment to Help Prepare Their Bodies for a Bone Marrow Transplant
Sponsor: Memorial Sloan Kettering Cancer Center
Summary
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).
Official title: Phase 2 Study of Personalized r-ATG Dosing to Improve Survival Through Enhanced Immune Reconstitution in Pediatric and Adult Patients Undergoing Ex-vivo CD34-Selected Allogeneic-HCT (PRAISE-IR)
Key Details
Gender
All
Age Range
4 Years - Any
Study Type
INTERVENTIONAL
Enrollment
59
Start Date
2021-04-30
Completion Date
2026-04
Last Updated
2025-09-04
Healthy Volunteers
No
Interventions
Personalized rATG (P-rATG)
P-rATG days (always starting on Day -12 to -10)
Hyper fractionated total body irradiation
(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.
Thiotepa
(5mg/kg/day x 2 day) Day -5 to -4
Cyclophosphamide
(60mg/kg/day x 2 days) Day -3 to -2
GCSF
Day +7
Busulfan
Day -9 to -7 doses 2-3 to be adjusted per PK for target cumulative exposure of 65 mg\*h/L
Melphalan
(70mg/m2/day x 2 days) Day -6 to -5
Fludarabine
(25mg/m2/day x 5 days) Day -6 to -2
Locations (1)
Memorial Sloan Kettering Cancer Center
New York, New York, United States