cancer therapy-related cardiac dysfunction
Conditions
Interventions
Control group in phase ?:Chemotherapy
Test group in phase ?:Chemotherapy+ Anakinra
Sponsors
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1.Aged less than 18 years at the time of study enrollment with newly diagnosed AML according to the 2016 WHO classification; 2.Patient and guardian consent to participate the study;
Exclusion criteria
Exclusion criteria: 1.The following myeloid leukemias: Philadelphia chromosome-positive AML; mixed-phenotype acute leukemia; acute promyelocytic leukemia; AML arising from myelodysplasia; myeloid proliferations of Down syndrome; therapy-related myeloid neoplasms; 2.Serious life-threatening organ dysfunction including, but not limited to: severe cardiac disease or abnormal baseline cardiac function (EF <50% or FS <24%); severe respiratory disease, severe renal, neurologic, endocrine, metabolic, immune, hepatic, gastrointestinal disorders, psychiatric disorders/social circumstances that may affect study adherence, etc. 3.Active infection requiring systemic antifungal/bacterial/viral therapy, including, but not limited to, HIV antibody positivity; hepatitis C antibody positivity or hepatitis C RNA greater than the upper limit of normal; HBsAg positivity with HBV-DNA greater than our center's reference range; within 1 week of normalization of temperature for a COVID-19 infection, or with unabsorbed pneumonia, or 1 week of recovery from other manifestations of severe disease; 4.congenital immunodeficiency disease; 5.Prior anti-tumor therapy; 6.Patient with weight < 10kg; 7.Allergy to Anakinra or any of its components; 8.Any symptom or condition of the subject that, in the judgment of the investigator, may affect the subject's safety or interfere with the evaluation of the efficacy and safety of the investigational drug, or any other circumstance or condition that makes the subject unsuitable for participation in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase ?: Occurrence of tumor treatment-related cardiac dysfunction (CTRCD) (2022 ESC Guidelines for Oncology Cardiology, Mild Asymptomatic CTRCD and More Severe CTRCD);Phase ?: Physical examination, vital signs, laboratory test results, and electrocardiogram changes;Phase ?: Dose-Limiting Toxicity;Phase ?: Incidence and Characteristics of Adverse Events/Severe Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase ?: Pharmacokinetics;Phase ?: Incidence and Characteristics of Adverse Events/Severe Adverse Events;Phase ?: Response to cancer treatment: percentage of complete remissions;Phase ?: Incidence of cardiac events;Phase ?: Event-free survival rate;Phase ?: Echocardiographic parameters;Phase ?: CRP NT-proBNP cTnT;Phase ?: Overall survival rate;Phase ?: Event-free survival rate;Phase ?: Incidence of cardiac events;Phase ?: CRP NT-proBNP cTnT;Phase ?: Non-cardiac toxicity: toxicity of the liver, kidneys, and hematopoietic system;Phase ?: Overall survival rate;Phase ?: Echocardiographic parameters;Phase ?: Physical examination, vital signs, laboratory test results, and electrocardiogram changes; | — |
Countries
China
Contacts
Public ContactZhang Hao
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed