Actively Recruiting
A Multicenter Phase II Study of Molecular Subtyping Combined With MRD-driven Induction Therapy in Children and Adolescents With AML
Led by Children's Hospital of Soochow University · Updated on 2024-08-22
500
Participants Needed
13
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying children and adolescents with acute myeloid leukemia (AML) to estimate the chance of achieving complete remission, including remission with incomplete blood count recovery, and to evaluate event-free survival and relapse rates. The study aims to see if combining molecular subtyping with measurable residual disease (MRD)-guided remission induction improves outcomes compared to the previous AML2018 treatment protocol. This is a Phase II multicenter clinical trial focusing on personalized treatment approaches based on genetic markers and MRD status. Treatment involves two main induction regimens assigned based on specific genetic fusion genes or mutations. Patients with certain fusion genes or KIT mutation receive a standard dose chemotherapy (SDC) regimen including homoharringtonine, cytarabine, and etoposide. Those without these genetic markers receive a low-dose chemotherapy (LDC) regimen combined with venetoclax. Targeted drugs such as venetoclax, avapritinib, gilteritinib, or sorafenib may be added based on individual molecular profiles. Post-induction, patients undergo 3 to 4 cycles of standard-dose chemotherapy, with high-risk patients considered for bone marrow transplantation. Participants will be closely monitored through scheduled assessments including blood counts and MRD evaluations at specific time points (Day 26 or 32 after inductions). Researchers will track remission status, event-free survival up to 72 months, and relapse incidence. Safety and treatment responses are evaluated continuously, with informed consent obtained from patients or guardians. The study involves detailed follow-up to assess treatment effects and long-term outcomes in this pediatric AML population.
CONDITIONS
Brief Title
Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed, untreated acute myeloid leukemia (AML)
- Under 18 years old
- Prior use of hydroxyurea or cytarabine allowed if cytarabine dose does not exceed 500 mg/m2 within 5 days
- Liver function: total bilirubin ≤ 2 times upper limit of normal, ALT/AST ≤ 3 times upper limit of normal
- Creatinine clearance ≥ 50 ml/min
- Cardiac function NYHA grade less than 3
- Oxygen saturation (SaO2) greater than 92%
- No active infection (symptoms resolved for more than 3 days if infected)
- ECOG performance status less than 2
- Expected survival time greater than 12 weeks
- Child and/or guardian consent and signed informed consent form
You will not qualify if you...
- Acute megakaryocytic leukemia (AMKL)
- Acute promyelocytic leukemia (APL)
- Treatment-related secondary AML or AML with definite MDS transformation
- Myeloproliferative neoplasm such as juvenile myelomonocytic leukemia (JMML)
- AML secondary to congenital bone marrow failure (e.g., Fanconi anemia)
- AML secondary to Down syndrome
- Only temporary chemotherapy, radiotherapy, or immunotherapy without systemic treatment as per protocol
- Significant concurrent disease or mental illness affecting safety, compliance, or consent
- Very poor nutritional status, severe infection, cardiac insufficiency, or chemotherapy intolerance
- Relapsed AML at any time
- Physician assessment of unsuitability due to physical condition, economic status, or other factors
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Induction therapy followed by consolidation cycles; total duration varies by treatment response and risk classification
Participants receive induction therapy based on their molecular subtype and measurable residual disease (MRD) status with chemotherapy regimens and targeted drugs. Post-induction consolidation therapy follows with 3 to 4 cycles of standard-dose chemotherapy according to risk classification, and high-risk participants may undergo allogeneic bone marrow transplantation.
Multiple visits during induction and consolidation cycles
Trial Site Locations
Total: 13 locations
1
First Affiliated Hospital Of University of Science and Technology of China
Hefei, Anhui, China, 230000
Not Yet Recruiting
2
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
Not Yet Recruiting
3
Guangzhou Women and Children Medical Center
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
4
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530000
Not Yet Recruiting
5
Kaifeng Children's Hospital
Kaifeng, Henan, China, 475000
Not Yet Recruiting
6
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
7
Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
Not Yet Recruiting
8
XiangYa Hospital Central South University
Changsha, Hunan, China, 410008
Not Yet Recruiting
9
Children's Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
10
Xuzhou Children's Hospital
Xuzhou, Jiangsu, China, 221000
Not Yet Recruiting
11
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250000
Not Yet Recruiting
12
Children's Hospital Of Fudan University
Shanghai, Shanghai Municipality, China, 200000
Not Yet Recruiting
13
Beijing Institute of Genomics, Chinese Academy of Sciences
Beijing, China, 100000
Not Yet Recruiting
Research Team
S
Shaoyan Hu, MD, PhD
L
Li Gao, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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