A Multi-Center Seamless Phase II-III Randomized Trial of High-dose Cytarabine in Initial Induction with Evaluation of Flow-cytometry-based Minimal Residual Disease for Children with de Novo Acute Myeloid Leukemia (AML-12)
- Conditions
- Acute Myeloid Leukemia
- Registration Number
- JPRN-UMIN000013288
- Lead Sponsor
- Japan Children's Cancer Group (JCCG)
- Brief Summary
Primary endpoints of this trial were early mortality rate in the Phase II part and 3-year EFS and rate of patients with positive flow-cytometric MRD at end-of-Induction-1 in the Phase III part. The main analyses of the Phase III part were performed for the 324 patients (ECM arm, N=168; HD-ECM arm, N=156) defined as FAS. 3-year EFS: ECM 64.3% (95%CI, 56.5-71.0%), HD-ECM 61.2% (95%CI, 53.1-68.4%), p=0.589 Positive FCM-MRD rate at TP1: ECM 21.5% (95%CI, 14.9-29.4%), HD-ECM 25.2% (95%CI, 17.9-33.7%), p=0.517
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 387
Not provided
1) Patients with severe CNS hemorrhage (grade 3 or higher in CTCAE ver4.0) 2) Patients with uncontrollable infection (including those with active tuberculosis or positive HIV antibody) 3) Patients who are pregnant or breast-feeding mother 4) Patients with history of primary or acquired immunodeficiency 5) Patients with uncontrollable heart failure; presence of heart anomaly itself is not an exclusion criteria 6) Patients with any other inappropriate status judged by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <Phase II study> Early death rate <Phase III study> 1) 3-year event-free survival (EFS) rate 2) Positive rate of flow-cytometry-based minimal residual disease (FCM-MRD) after initial induction course (TP-1)
- Secondary Outcome Measures
Name Time Method