NCT06221683RecruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 22 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 4 Jan 2024
- Start date
- 1 Jan 2024
- Primary completion date
- Dec 2028
- Lead sponsor
- Children's Hospital of Soochow University
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT06221683
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 500
- From 1 Jan 2024 to the primary completion date, Dec 2028
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 5、AML secondary to congenital bone marrow failure (such as AML secondary to Fanconi anemia (FA);
- 6、AML secondary to Down syndrome;
- 10、Patients with very poor nutritional status, severe infection, cardiac insufficiency, and intolerance to chemotherapy;
- 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.
Other
- 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);
- 11、Relapsed AML at any time;
Who the study is looking for
- 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.
Age in the registry: - to 18 years · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Institute of Genomics, Chinese Academy of Sciences Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| Third Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| Guangzhou Women and Children Medical Center Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| The Second Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Not yet recruiting |
| First Affiliated Hospital Of University of Science and Technology of China Coordinator of this site? Confirm its status | Hefei | China | Not yet recruiting |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Not yet recruiting |
| Kaifeng Children's Hospital Coordinator of this site? Confirm its status | Kaifeng | China | Not yet recruiting |
| The First Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Not yet recruiting |
| Children's Hospital Of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Children's Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Xuzhou Children's Hospital Coordinator of this site? Confirm its status | Xuzhou | China | Not yet recruiting |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.