Implementation of targeted therapy during remission induction chemotherapy of de novo pediatric acute myeloid leukemia to improve rates of complete remission

The Catholic University of Korea, Seoul St. Mary's Hospital0 个研究点目标入组 170 人开始时间: 待定最近更新: 2021年8月30日

适应症

试验速览

暂无简介。

•1) Age 0-18
•2) Newly diagnosed de novo AML (bone marrow (BM) blast = 20%), no previous therapy
•3) Patients with recurrent genetic abnormalities found in AML, such as t(8;21), inv(16), t(16;16), even if the BM blast percentage is less than 20%
•4) Patients who failed to achieve morphological and cytogenetic CR. Cytogenetic CR refers to any cytogenetic clone found at diagnosis (for example -7, 5q-) normalizing to 46, XX or 46, XY. If the patient had a normal karyotype at diagnosis, then only the morphology of the follow-up BM study will be used to determine CR.

•1) Acute promyelocytic leukemia (AML, M3)
•2) Down syndrome AML
•3) Therapy-related AML
•4) AML that developed from myelodysplastic syndrome or other BM failure syndrome
•5) Isolated myeloid sarcoma with normal BM
•6) Serious complications (severe infection, intracranial bleeding) that prevent the start of normal chemotherapy
•7) If the patient or legal guardian wishes to withdraw from the clinical trial
•8) Presence of non-hematologic organ toxicity, as defined below
•- serum creatinine = 3 x upper normal limit
•- ejection fraction < 40%, or severe arrhythmia or conduction abnormality
•9) Contraindications to targeted chemotherapy

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