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RECRUITINGPhase 2INTERVENTIONAL

Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML

A Multicenter Clinical Study of Molecular Subtyping Combined With MRD-driven Remission Induction Regimen in Children and Adolescents With AML: A Phase II Cohort Study (GMCAII)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The goal of this clinical trial is to estimate the rate (probability) of complete remission or complete remission with incomplete count recovery (CR/CRi) with negative MRD after induction I and II, event-free survival (EFS), and cumulative incidence (probability) of relapse (CIR), in patients receiving molecular/precision medicine and MRD-driven remission inductions, and to assess secondarily if there is an improvement over the AML2018 protocol.

Who May Be Eligible (Plain English)

Who May Qualify: - 1、Newly diagnosed, untreated AML; - 2、Under 18 years old; - 3、Patients who have used hydroxyurea or cytarabine before diagnosis, but the dosage of cytarabine does not exceed 5 days, and the total dose does not exceed 500 mg/m2 (50 mg/m2, q12h × 5d); - 4、 Liver function:Tbil≤2×ULN, ALT/AST≤3×ULN, kidney function (creatinine clearance) at least 50ml/min;Cardiac NYHA grading\<3;SaO2\>92%; - 5、No active infection (symptoms resolved for more than 3 days if infected) - 6、ECOG\<2; - 7、Expected survival time greater than 12 weeks; - 9、Obtain the consent of the child and/or guardian and sign the willing to sign a consent form form. Who Should NOT Join This Trial: - 1、Acute megakaryocytic leukemia (AMKL); - 2、Acute promyelocytic leukemia (APL); - 3、Treatment-related secondary AML and AML with definite MDS transformation; - 4、Myeloproliferative neoplasm (such as Juvenile myelomonocytic leukemia, JMML); - 5、AML secondary to congenital bone marrow failure (such as AML secondary to Fanconi anemia (FA); - 6、AML secondary to Down syndrome; - 7、Only temporary chemotherapy, radiotherapy, or immunotherapy, but not systematic treatment according to the treatment plan; - 8、 Temporary chemotherapy, radiotherapy, or immunotherapy only, not systemic therapy per protocol; - 9、Having any significant abnormal concurrent disease or mental illness that impacts the life safety and compliance of the patient and impacts willing to sign a consent form, study participation, follow-up, or interpretation of results. In this case, all the participating units are required to report directly to the responsible person for this project to jointly decide whether they meet the exclusion criteria; - 10、Patients with very poor nutritional status, severe infection, cardiac insufficiency, and intolerance to chemotherapy; - 11、Relapsed AML at any time; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 1、Newly diagnosed, untreated AML; * 2、Under 18 years old; * 3、Patients who have used hydroxyurea or cytarabine before diagnosis, but the dosage of cytarabine does not exceed 5 days, and the total dose does not exceed 500 mg/m2 (50 mg/m2, q12h × 5d); * 4、 Liver function:Tbil≤2×ULN, ALT/AST≤3×ULN, creatinine clearance ≥50ml/min;Cardiac NYHA grading\<3;SaO2\>92%; * 5、No active infection (symptoms resolved for more than 3 days if infected) * 6、ECOG\<2; * 7、Expected survival time greater than 12 weeks; * 9、Obtain the consent of the child and/or guardian and sign the informed consent form. Exclusion Criteria: * 1、Acute megakaryocytic leukemia (AMKL); * 2、Acute promyelocytic leukemia (APL); * 3、Treatment-related secondary AML and AML with definite MDS transformation; * 4、Myeloproliferative neoplasm (such as Juvenile myelomonocytic leukemia, JMML); * 5、AML secondary to congenital bone marrow failure (such as AML secondary to Fanconi anemia (FA); * 6、AML secondary to Down syndrome; * 7、Only temporary chemotherapy, radiotherapy, or immunotherapy, but not systematic treatment according to the treatment plan; * 8、 Temporary chemotherapy, radiotherapy, or immunotherapy only, not systemic therapy per protocol; * 9、Having any significant abnormal concurrent disease or mental illness that impacts the life safety and compliance of the patient and impacts informed consent, study participation, follow-up, or interpretation of results. In this case, all the participating units are required to report directly to the responsible person for this project to jointly decide whether they meet the exclusion criteria; * 10、Patients with very poor nutritional status, severe infection, cardiac insufficiency, and intolerance to chemotherapy; * 11、Relapsed AML at any time; * 12、The attending physician considers that the patient is not suitable for entering the study protocol based on the patient's physical condition, economic status, and other factors.

Treatments Being Tested

DRUG

Homoharringtonine

3mg/m2/day for weighing \>10kg, 0.1mg/kg/day for weighing ≤10kg, d1-7, ivgtt, qd, more than 6 hours

DRUG

Cytarabine

100mg/m2/q12h for weighing \>10kg, 3.3mg/kg/q12h for weighing ≤10kg, d1-7, ivgtt, q12h, more than 30 minutes in SDC group; 10mg/m2/q12h for weighing \>10kg, 0.33mg/kg/q12h for weighing ≤10kg, d1-10, s.c.,q12h (the first dose at 8 am) in the LDC group;

DRUG

Etoposide

100mg/m2/d for weighing \>10kg, 3.3mg/kg/d for weighing ≤ 10kg, d1-5, ivgtt, qd, more than 4 hours

DRUG

Venetoclax

100mg/m2/d for weighing \>10kg, 3.33mg/kg/d for weighing ≤10kg, d12-25, po, qd

DRUG

Mitoxantrone hydrochloride liposome

5mg/m2/d for weighing \>10kg, 0.17mg/kg/d for weighing ≤ 10kg, d1, 3, 5, ivgtt, qod, more than 2 hours at 10 am.

DRUG

Recombinant Human Granulocyte Colony-Stimulating Factor

5ug/kg/d, d1-10, s.c., qd, at 1pm

DRUG

Idarubicin Hydrochloride

3mg/m2/day for weighing \>10kg, 0.1mg/kg/day for weighing ≤ 10kg, d1-7, ivgtt, qd, more than 6 hours.

DRUG

Sorafenib

100mg/m2/day for weighing \>10kg, 3.3mg/kg/day for weighing ≤10kg, from identification, po, qd

DRUG

Gilteritinib

20mg/m2/day for weighing \>10kg, 0.7mg/kg/day for weighing ≤ 10kg, from identification, po, qd

DRUG

Avapritinib

50mg/m2/day for weighing bodyweight \>10kg, 1.65mg/kg/day for weighing ≤ 10kg, po, qd

Locations (13)

First Affiliated Hospital Of University of Science and Technology of China
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Guangzhou Women and Children Medical Center
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Kaifeng Children's Hospital
Kaifeng, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Third Xiangya Hospital of Central South University
Changsha, Hunan, China
XiangYa Hospital Central South University
Changsha, Hunan, China
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Xuzhou Children's Hospital
Xuzhou, Jiangsu, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Children's Hospital Of Fudan University
Shanghai, Shanghai Municipality, China
Beijing Institute of Genomics, Chinese Academy of Sciences
Beijing, China