Clinical trial · Interventional
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)
NCT06221683CI-TRIAL-00080102GMCAIIrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| AML, Childhood | Childhood Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avapritinib | Drug | Avapritinib | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Gilteritinib | Drug | Gilteritinib | ALIAS |
| Homoharringtonine | Drug | Omacetaxine Mepesuccinate | ALIAS |
| Idarubicin Hydrochloride | Drug | Idarubicin | ALIAS |
| Mitoxantrone hydrochloride liposome | Drug | — | UNRESOLVED |
| Recombinant Human Granulocyte Colony-Stimulating Factor | Drug | Filgrastim |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SDC group
- description
- Patients with CBF fusion gene (RUNX1: : RUNX1T1 and CBFB: : MYH11) or KMT2A: : MLLT3(AF9) , KMT2A: : MLLT10(AF10) , KMT2A: : MLLT4(AF6) fusion gene or KIT mutation will receive SDC regimen, including one course of HAE (Homoharringtonine, cytarabine, etoposide) in induction I. These patients will continue on the SDC (HAE) regimen in the second course if the MRD is \< 1% after induction I, otherwise venetoclax will be added to the SDC group sequentially on Day 2 after the end of HAE. FLT3-ITD will be given sorafenib or gilteritinib as early as possible, and patients with KIT mutations will be recommended to add avapritinib as appropriate. These targeted drugs will not be combined with venetoclax.
- interventionNames
- Drug: Homoharringtonine
- Drug: Cytarabine
- Drug: Etoposide
- Drug: Venetoclax
- Drug: Sorafenib
- Drug: Gilteritinib
- Drug: Avapritinib
- type
- EXPERIMENTAL
- label
- LDC group
- description
- Patients with the exception of the CBF fusion gene (RUNX1: : RUNX1T1 and CBFB: : MYH11) or those with the KMT2A: : MLLT3(AF9) , KMT2A: : MLLT10(AF10) , KMT2A: : MLLT4(AF6) fusion gene or KIT mutation will receive the LDC (MAG/IDAG+ venetoclax) regimen in induction I. Patients with MRD ≥1% or KIT mutations, assessed after induction I, will receive the HAE plus venetoclax (or targeted drugs) regimen, otherwise, they will receive MAG/IDAG + venetoclax. FLT3-ITD will be given sorafenib or gilteritinib as early as possible, and patients with KIT mutations will be recommended to add avapritinib as appropriate. These targeted drugs will not be combined with venetoclax.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.