Molecular Subtype Combined with Early Minimal Residual Disease to Optimize the Treatment of Newly Diagnosed Acute Myeloid Leukemia

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

218

Participants

Timeline

Start Date

October 30, 2024

Primary Completion Date

October 31, 2026

Study Completion Date

June 30, 2027

Conditions
Acute Myeloid Leukemia (AML)
Interventions
DRUG

D5-PBCR(-) IA arm

"Induction: IA Drug: idarubicin, intravenously, 10 mg/m\^2 on D1-3 Drug: cytarabine, intravenously, 100 mg/m\^2 on D1-7~Consolidation:~Subjects who achieve composite complete remission (CRc) proceed with consolidation therapy.~In consolidation therapy phase, subjects in the group with favorable/intermediate risk and MRD negetive, will receive cytarabine intravenously at 2g/m\^2/q12h\*6 doses. Subjects in the group with adverse risk or MRD positive will receive cytarabine intravenously at 2g/m\^2/q12h\*6 doses together with venetoclax 400mg on D4-10. Dose ramp-up of venetoclax is not required.~After two cycles of consolidation, a multi-disciplinary team will discuss whether the patient need allogeneic hematopoietic stem-cell transplant (allo-HSCT) according to ELN risk stratification and MRD status."

DRUG

D5-PBCR(+) IA+Venetoclax arm

"Induction: IA+Ven Drug: idarubicin, intravenously, 10 mg/m\^2, on D1-3, Drug: cytarabine, intravenously, 100 mg/m\^2 on D1-7 For D5-PBCR (+) patients, Venetoclax will be combined. Drug: Venetoclax. Orally once daily, on D6-14. A 3-day dose ramp-up is required for the first induction (100mg D6, 200mg D7, 400mg D8-14) If a second induction is needed, the dose of IA is the same as the first cycle, and dose ramp-up of venetoclax is not required.~Consolidation:~Subjects who achieve composite complete remission (CRc) proceed with consolidation therapy.~In consolidation therapy phase, subjects in the group will receive cytarabine intravenously at 2g/m\^2/q12h\*6 doses together with venetoclax 400mg on D4-10. Dose ramp-up of venetoclax is not required.~After two cycles of consolidation, a multi-disciplinary team will discuss whether the patient need allogeneic hematopoietic stem-cell transplant (allo-HSCT) according to ELN risk stratification and MRD status."

Trial Locations (1)

Unknown

Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai

All Listed Sponsors
lead

Ruijin Hospital

OTHER

NCT06652685 - Molecular Subtype Combined with Early Minimal Residual Disease to Optimize the Treatment of Newly Diagnosed Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter