Testing the Use of Combination Therapy in Patients With Persistent Low Level Acute Myeloid Leukemia (AML) Following Initial Treatment

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

184

Participants

Timeline

Start Date

October 23, 2024

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2027

Conditions
Leukemia, Myeloid, Acute
Interventions
DRUG

Cytarabine

Arm A: CBF-Cytarabine 3000 mg/m2 or 1500 mg/m2 IV twice daily (BID), 12 hours apart x 6 doses either on Days 1, 3, and 5 OR Days 1, 2, and 3

DRUG

Venetoclax

Venetoclax 100 mg daily Day 1 through Day 8 Venetoclax 400 mg orally once daily on Days 1-14 Venetoclax 400 mg orally once daily on Days 1-28

DRUG

CPX-351

Daunorubicin 29 mg/m2/Cytarabine 65 mg/m2 liposome IV on Days 1 and 3

DRUG

Azacitidine

Azacitidine 75 mg/m2 IV/SC on Days 1-7 OR Days 1-5 and Days 8-9 (per institutional preference)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Eastern Cooperative Oncology Group

NETWORK

NCT05628623 - Testing the Use of Combination Therapy in Patients With Persistent Low Level Acute Myeloid Leukemia (AML) Following Initial Treatment | Biotech Hunter | Biotech Hunter