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) (AML-12)

未提供0 个研究点目标入组 300 人开始时间: 2014年4月4日最近更新: 2024年3月31日

适应症

试验速览

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•AML [excluding APL, AML with Down syndrome (ML-DS), secondary AML, AML developed after MDS, NK/myeloid leukemia, and granulocytic sarcoma]
•Age 0 year to 18 years old at diagnosis; for neonates aged 30 days or less, patients must be >= 36 weeks gestational age at the time of diagnosis
•ECOG performance status (PS) score of 0-2; those with PS score 3 is eligible if that is derived from AML
•newly diagnosed AML without history of previous chemotherapy or radiation therapy; those with history of steroid therapy, ATRA (because of suspicion of APL), or single intrathecal methotrexate therapy (because of suspicion of ALL) are eligible
•Patients must have sufficient organ function satisfying the laboratory data listed below (should be evaluated within 7 days of study enrollment);
•T-Bil: within 3x of the age-dependent normal range
•Cre: within 3x of the age-dependent normal range
•All patients and/or their parents or legal guardians must sign a written informed consent.

•Patients with severe CNS hemorrhage (grade 3 or higher in CTCAE ver4.0)
•Patients with uncontrollable infection (including those with active tuberculosis or positive HIV antibody)
•Patients who are pregnant or breast-feeding mother
•Patients with history of primary or acquired immunodeficiency
•Patients with uncontrollable heart failure; presence of heart anomaly itself is not an exclusion criteria
•Patients with any other inappropriate status judged by physician

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