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New treatment option for AML, Childhood
Official title Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML
ClinicalTrials.gov ID: NCT06221683
What this study is testing
What is Homoharringtonine?
Homoharringtonine is an investigational medicine, being studied as a potential treatment for aml, childhood.
Also referred to as Homoharringtonine injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 18
You may be able to join if
- 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...
- 4、 Liver function：Tbil≤2×ULN, ALT/AST≤3×ULN, creatinine clearance ≥50ml/min；Cardiac NYHA grading\ 92%;
- 5、No active infection (symptoms resolved for more than 3 days if infected)
You likely can't join if
- 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;
See the full eligibility 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\ 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Kaifeng, Henan, China
- Zhengzhou, Henan, China
- Changsha, Hunan, China
- Suzhou, Jiangsu, China
- Xuzhou, Jiangsu, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Guangzhou, Guangdong, China; Nanning, Guangxi, China; Kaifeng, Henan, China; Zhengzhou, Henan, China; Changsha, Hunan, China and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.