pediatric acute myeloid leukemia
Conditions
Interventions
Group A:IAE
Group B:C+HAG
Sponsors
Institute of Hematology, Blood Disease Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. Age <18 years old; 2. Non-M3-AML patients diagnosed according to the 2016 revised WHO criteria; 3. Informed consent signed by the child and/or parent or legal guardian; 4. Bilirubin <= (the same age) 3 times the upper limit of normal value; 5. AST and ALT<= (same age) 5 times of the upper limit of normal value; 6. Creatinine <= (same age) 2 times the upper limit of normal value; 7. Good cardiac function, defined as an ejection fraction greater than 50% on echocardiography or MUGA scan.
Exclusion criteria
Exclusion criteria: 1. Acute promyelocytic leukemia, chronic myelocytic leukemia, acute mixed cell leukemia, or known central nervous system leukemia; 2. AML associated with congenital syndromes such as Down syndrome, Fanconi anemia, Bloom syndrome, Koch's syndrome, or congenital aplastic anemia; 3. Human immunodeficiency virus (HIV) positive; 4. There is active systemic infection; 5. Any medical history or concomitant disease that the investigator considers to be detrimental to the subject's safe completion of the study; 6. The investigator determines that the subject is medically unfit to receive the study drug or is unfit for any other reason; 7. Known or suspected allergy to the drug under test or to any drug administered in connection with the study; 8. Participated in a drug trial within the past 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate after reinduction therapy (CR+CRi); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Objective response rate;Overall survival;Minimal residual disease;Adverse events;Absolute Neutrophil Count; | — |
Countries
China
Contacts
Public ContactZhu Xiaofan
Institute of Hematology, Blood Disease Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed