40
Participants
Start Date
March 31, 2023
Primary Completion Date
November 30, 2026
Study Completion Date
January 31, 2027
Venetoclax
"Dose Level 0: Day 1 60 mg/m2 PO x1, Days 2-14 120 mg/m2/dose PO once daily (Max: 200 mg/day)~Dose level 1: Day 1 120 mg/m2 PO x1, Days 2-14 240 mg/m2/dose PO once daily (Max: 400 mg/day)~Dose level 2: Day 1 180 mg/m2 PO x1, Days 2-14 360 mg/m2/dose PO once daily (Max: 600 mg/day)"
Azacitadine
75 mg/m2/dose IV once daily over 15 minutes
Vorinostat
"1 year to 17.99 years old: 180 mg/m2/dose PO once daily~≥18 years old 200 mg PO BID. Doses should be separated by 12 hr (±4 hr)"
Cytarabine
"2000 mg/m2/dose IV once daily over 3 hours~IT Cytarabine:~1. \- 1.99 years old: 30 mg~2. \- 2.99 years old: 50 mg~ * 3 years old: 70 mg"
Fludarabine
30 mg/m2/dose IV once daily over 30 minutes
Filgrastim
5 microgram/kg/dose subcutaneous (or IV over 15-30 min) once daily
RECRUITING
Children's Wisconsin, Milwaukee
Medical College of Wisconsin
OTHER