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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

April 30, 2021

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
Acute Myeloid Leukemia (AML)Acute Lymphoid Leukemia (ALL)Myelodysplastic Syndromes (MDS)
Interventions
OTHER

Personalized rATG (P-rATG)

P-rATG days (always starting on Day -12 to -10)

RADIATION

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."

DRUG

Thiotepa

(5mg/kg/day x 2 day) Day -5 to -4

DRUG

Cyclophosphamide

(60mg/kg/day x 2 days) Day -3 to -2

DRUG

GCSF

Day +7

DRUG

Busulfan

Day -9 to -7 doses 2-3 to be adjusted per PK for target cumulative exposure of 65 mg\*h/L

DRUG

Melphalan

(70mg/m2/day x 2 days) Day -6 to -5

DRUG

Fludarabine

(25mg/m2/day x 5 days) Day -6 to -2

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER