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OncoMatch/Clinical Trials/NCT06221683

Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML

Is NCT06221683 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for aml, childhood.

Phase 2RecruitingChildren's Hospital of Soochow UniversityNCT06221683Data as of Jun 2026Location: China

Treatment: Homoharringtonine · Cytarabine · Etoposide · Venetoclax · Mitoxantrone hydrochloride liposome · Recombinant Human Granulocyte Colony-Stimulating Factor · Idarubicin Hydrochloride · Sorafenib · Gilteritinib · AvapritinibThe 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.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

VenetoclaxSorafenibGilteritinibAvapritinib

Chemotherapy

CytarabineEtoposideIdarubicin Hydrochloride

Other

HomoharringtonineMitoxantrone hydrochloride liposomeRecombinant Human Granulocyte Colony-Stimulating Factor

Cancer type

Acute Myeloid Leukemia

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 18

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic chemotherapy

Exception: hydroxyurea or cytarabine before diagnosis, cytarabine ≤ 5 days and total dose ≤ 500 mg/m2

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)

Cannot have received: chemotherapy, radiotherapy, or immunotherapy

Exception: temporary only, not systemic therapy per protocol

Only temporary chemotherapy, radiotherapy, or immunotherapy, but not systematic treatment according to the treatment plan

Cannot have received: chemotherapy, radiotherapy, or immunotherapy

Exception: temporary only, not systemic therapy per protocol

Temporary chemotherapy, radiotherapy, or immunotherapy only, not systemic therapy per protocol

Lab requirements

Kidney function

creatinine clearance ≥50ml/min

Liver function

Tbil≤2×ULN, ALT/AST≤3×ULN

Cardiac function

NYHA grading<3; SaO2>92%

Liver function:Tbil≤2×ULN, ALT/AST≤3×ULN, creatinine clearance ≥50ml/min;Cardiac NYHA grading<3;SaO2>92%;

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06221683 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Is there an age limit?

Yes. Patients must be 18 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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