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

Sponsor
Ruijin Hospital
Study ID
NCT06652685
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex
ALL
Age
18 Years - 59 Years
Healthy Volunteers
Not accepted

Interventions

  • D5-PBCR(-) IA arm — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 30, 2024
Status verified
Oct 2024
Primary completion
Oct 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
218 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: D5-PBCR(-)
    On day five of IA induction, D5-PBCR will be tested according to protocol. For D5-PBCR (-) patients, no additional of venetoclax is needed.
  • Experimental: D5-PBCR(+)
    On day five of induction, D5-PBCR will be tested according to protocol. D5-PBCR (+) patients, will receive induction therapy consisting of venentoclax combined with IA regimen.

Primary Outcome Measure

Composite complete remission rate [ Time Frame: At the end of cycle one (up to 42 days from the start of cycle 1） ]

Central Contacts

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