A Multicenter Clinical Study of Molecular Subtyping Combined With MRD-driven Remission Induction Regimen in Children and Adolescents With AML: A Phase II Cohort Study (GMCAII)

NCT06221683 Phase 2 RECRUITING

The goal of this clinical trial is to estimate the rate (probability) of complete remission or complete remission with incomplete count recovery (CR/CRi) with negative MRD after induction I and II, event-free survival (EFS), and cumulative incidence (probability) of relapse (CIR), in patients receiving molecular/precision medicine and MRD-driven remission inductions, and to assess secondarily if there is an improvement over the AML2018 protocol.

Details

Lead sponsor	Children's Hospital of Soochow University
Phase	Phase 2
Status	RECRUITING
Enrolment	500
Start date	2024-01-01
Completion	2029-12

Conditions

• AML, Childhood
• Acute Myeloid Leukemia

Interventions

• Homoharringtonine
• Cytarabine
• Etoposide
• Venetoclax
• Mitoxantrone hydrochloride liposome
• Recombinant Human Granulocyte Colony-Stimulating Factor
• Idarubicin Hydrochloride
• Sorafenib
• Gilteritinib
• Avapritinib

Primary outcomes

• Rate of CR/CRi with negative MRD — Day 26 (HAE group) and Day 32 (MAG+Ven group) for remission induction 1 and 2 are the necessary time points for response evaluation.
  CR/CRi with negative MRD was defined as less than 5% blasts in bone marrow and MRD \<0.1%.
• Event-free survival — From date of treatment until the date of the occurrence of the event, whichever comes first, assessed up to 72 months. Patients remaining event-free are censored at the last follow-up time.
  Events/failures of EFS include any-cause death, relapse, second malignancy, no CR after Indiction II and off-therapy due to abandonment or attending physician's decision. Induction II and off-therapy due to abandonment or attending physician's decision.
• Cumulative incidence of relapse — From date of treatment until the date of when a failure of CIR occurs, whichever comes first, assessed up to 72 months.
  Failures of CIR only include relapse and no CR after Induction 2. Other failures including death in resission (before repalse), second malignancy, and off-therapy due to abandonment or attending physician's decision are considered competing risk.

Countries

China