Venetoclax to Augment Epigenetic Modification and Chemotherapy

PHASE1RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 31, 2023

Primary Completion Date

November 30, 2026

Study Completion Date

January 31, 2027

Conditions
Acute Myeloid Leukemia, in RelapseAcute Myeloid Leukemia Refractory
Interventions
DRUG

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)"

DRUG

Azacitadine

75 mg/m2/dose IV once daily over 15 minutes

DRUG

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)"

DRUG

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"

DRUG

Fludarabine

30 mg/m2/dose IV once daily over 30 minutes

DRUG

Filgrastim

5 microgram/kg/dose subcutaneous (or IV over 15-30 min) once daily

Trial Locations (1)

53226

RECRUITING

Children's Wisconsin, Milwaukee

All Listed Sponsors
lead

Medical College of Wisconsin

OTHER