Actively Recruiting
Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD 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
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 5 days and total dose is 500 mg/m2 or less
- Liver function: total bilirubin 4 mg/dL (2x upper limit of normal), ALT/AST 9 mg/dL (3x upper limit of normal), creatinine clearance 50 ml/min
- Cardiac function NYHA grade less than 3
- Oxygen saturation above 92%
- No active infection or symptoms resolved for more than 3 days
- ECOG performance status less than 2
- Expected survival time greater than 12 weeks
- Informed consent obtained from the child and/or guardian
You will not qualify if you...
- Acute megakaryocytic leukemia (AMKL)
- Acute promyelocytic leukemia (APL)
- Treatment-related secondary AML and AML with definite myelodysplastic syndrome (MDS) transformation
- Myeloproliferative neoplasm such as juvenile myelomonocytic leukemia (JMML)
- AML secondary to congenital bone marrow failure such as Fanconi anemia
- AML secondary to Down syndrome
- Only temporary chemotherapy, radiotherapy, or immunotherapy without systemic treatment per protocol
- Significant abnormal concurrent disease or mental illness affecting patient safety, consent, participation, or results
- Very poor nutritional status, severe infection, cardiac insufficiency, or chemotherapy intolerance
- Relapsed AML at any time
- Physician judgment that patient is unsuitable for the study based on physical condition, economic status, or other factors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
L
Li Gao, MD
CONTACT
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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