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Molecular Subtype Combined with Early Minimal Residual Disease to Optimize the Treatment of Newly Diagnosed Acute Myeloid Leukemia
Sponsor: Ruijin Hospital
Summary
This study aims to investigate the safety and efficacy of drug "X" in combination with intensive chemotherapy in subjects with newly diagnosed AML (excluding APL and CBF-AML). "X" drugs included BCL-2 inhibitor venetoclax and FLT3 inhibitor Gilteritinib. Subjects will receive standard intensive chemotherapy during induction and consolidation. Early induction response will be evaluated according to the results of peripheral blood blast clearance rate on the fifth day after induction therapy (D5-PBCR). Venetoclax will be added in D5-PBCR positive subjects. For subjects with FLT3 mutations, Gilteritinib will be combined. Subjects will be stratified based on the genetic risk classification of 2022 European LeukemiaNet recommendations (ELN risk) and MRD status to receive specific consolidation therapy after the induction therapy.
Official title: Molecular Subtype Combined with Early Minimal Residual Disease to Optimize the Treatment of Young Treatment-naive Acute Myeloid Leukemia: a Multicenter, Phase II Study
Key Details
Gender
All
Age Range
18 Years - 59 Years
Study Type
INTERVENTIONAL
Enrollment
218
Start Date
2024-10-30
Completion Date
2027-06-30
Last Updated
2024-10-22
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (1)
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China