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

ConditionsAML, ChildhoodAcute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorChildren's Hospital of Soochow University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%;

Disqualifiers

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);

Trial design

Design model

Factorial

Treatments tested in this trial

  • Homoharringtonine

    Drug

    3mg/m2/day for weighing \>10kg, 0.1mg/kg/day for weighing ≤10kg, d1-7, ivgtt, qd, more than 6 hours

  • Cytarabine

    Drug

    100mg/m2/q12h for weighing \>10kg, 3.3mg/kg/q12h for weighing ≤10kg, d1-7, ivgtt, q12h, more than 30 minutes in SDC group; 10mg/m2/q12h for weighing \>10kg, 0.33mg/kg/q12h for weighing ≤10kg, d1-10, s.c.,q12h (the first dose at 8 am) in the LDC group;

  • Etoposide

    Drug

    100mg/m2/d for weighing \>10kg, 3.3mg/kg/d for weighing ≤ 10kg, d1-5, ivgtt, qd, more than 4 hours

  • Venetoclax

    Drug

    100mg/m2/d for weighing \>10kg, 3.33mg/kg/d for weighing ≤10kg, d12-25, po, qd

  • Mitoxantrone hydrochloride liposome

    Drug

    5mg/m2/d for weighing \>10kg, 0.17mg/kg/d for weighing ≤ 10kg, d1, 3, 5, ivgtt, qod, more than 2 hours at 10 am.

  • Recombinant Human Granulocyte Colony-Stimulating Factor

    Drug

    5ug/kg/d, d1-10, s.c., qd, at 1pm

  • Idarubicin Hydrochloride

    Drug

    3mg/m2/day for weighing \>10kg, 0.1mg/kg/day for weighing ≤ 10kg, d1-7, ivgtt, qd, more than 6 hours.

  • Sorafenib

    Drug

    100mg/m2/day for weighing \>10kg, 3.3mg/kg/day for weighing ≤10kg, from identification, po, qd

  • Gilteritinib

    Drug

    20mg/m2/day for weighing \>10kg, 0.7mg/kg/day for weighing ≤ 10kg, from identification, po, qd

  • Avapritinib

    Drug

    50mg/m2/day for weighing bodyweight \>10kg, 1.65mg/kg/day for weighing ≤ 10kg, po, qd

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: SDC groupExperimental treatment 7 interventions
Group B: LDC groupExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Rate of CR/CRi with negative MRD

CR/CRi with negative MRD was defined as less than 5% blasts in bone marrow and MRD \<0.1%.

Time frame
Day 26 (HAE group) and Day 32 (MAG+Ven group) for remission induction 1 and 2 are the necessary time points for response evaluation.
2

Event-free survival

Events/failures of EFS include any-cause death, relapse, second malignancy, no CR after Indiction II and off-therapy due to abandonment or attending physician's decision. Induction II and off-therapy due to abandonment or attending physician's decision.

Time frame
From date of treatment until the date of the occurrence of the event, whichever comes first, assessed up to 72 months. Patients remaining event-free are censored at the last follow-up time.
3

Cumulative incidence of relapse

Failures of CIR only include relapse and no CR after Induction 2. Other failures including death in resission (before repalse), second malignancy, and off-therapy due to abandonment or attending physician's decision are considered competing risk.

Time frame
From date of treatment until the date of when a failure of CIR occurs, whichever comes first, assessed up to 72 months.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov
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