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RecruitingLast updated: 31 January 2024

MyeChild: This phase III trial is comparing two induction chemotherapy treatments in children with Acute Myeloid Leukaemia (AML)International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia - Incorporating an Embedded Dose Finding Study for Gemtuzumab Ozogamicin in Combination With Induction Chemotherapy

Clinical summary

Summary

This trial is comparing two induction chemotherapy regimens: mitoxantrone and cytarabine (current standard treatment) with liposomal daunorubicin and cytarabine. Patients responding well to induction chemotherapy are eligible for a randomisation of two consolidation regimens: high dose cytarabine (current standard treatment) or fludarabine and cytarabine (FLA); a regimen commonly used in patients with relapsed disease, testing whether FLA is more effective in front line therapy than standard consolidation treatment. Patients with cytogenetic features associated with a higher risk of relapse and those responding sub-optimally to induction treatment are candidates for haemopoietic stem cell transplant (HSCT) and are eligible for a randomisation comparing two HSCT conditioning regimens: myeloablative conditioning (MAC) (current UNited Kingdom (UK) standard) or reduced intensity conditioning (RIC). This trial also incorporates a dose finding study for gemtuzumab ozogamicin.

Conditions

This trial is treating patients with acute myeloid leukaemia (AML).

Cancer

Blood Cancers Haematological

Age

People>17

Phase

III

Trial Acronym

MyeChild

More information

Trial Identifiers

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Trial sponsor

University of Birmingham

Scientific Title

International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia - Incorporating an Embedded Dose Finding Study for Gemtuzumab Ozogamicin in Combination With Induction Chemotherapy

Eligibility

Inclusion

Inclusion criteria for trial entry

  • Diagnosis of acute myeloid leukaemia (AML) /high risk Myelodysplastic syndrome (MDS) (>10% blasts in the bone marrow)/isolated myeloid sarcoma (MS) (either de novo or secondary).
  • Age <18 years at trial entry.
  • No prior chemotherapy or biological therapy for AML/high risk MDS/isolated MS other than that permitted in the protocol.
  • Normal cardiac function defined as fractional shortening ≥28% or ejection fraction ≥55%.
  • Fit for protocol chemotherapy.
  • Documented negative pregnancy test for female patients of childbearing potential.
  • Patient agrees to use effective contraception (patients of child bearing potential).
  • Written informed consent from the patient and/or parent/legal guardian.

Inclusion criteria for participation in the gemtuzumab ozogamicin dose finding study:

Centres must be formally activated in order to be take part in the embedded dose escalation study. Please contact the trial office for further information.

  • Patient meets the inclusion criteria for trial entry.
  • Age:

    • ≥12 months for the major dose finding study
    • ≥ 12 weeks and <12 months for the minor dose finding study
  • Normal renal function defined as calculated creatinine clearance ≥90ml/min/1.73m2.
  • Normal hepatic function defined as total bilirubin ≤2.5 upper limit of normal (ULN) for age unless it is caused by leukaemic involvement or Gilbert's syndrome or similar disorder.
  • Alanine transaminase (ALT) or aspartate transaminase (AST) ≤10 x ULN for age.
  • Written informed consent from the patient and/or parent/legal guardian.

Inclusion criteria for treatment with gemtuzumab ozogamicin for patients not participating in the gemtuzumab ozogamicin dose finding study or R2.

  • Patient meets the inclusion criteria for trial entry (section 4.1.1)
  • Age:

    • ≥12 months
    • ≥ 12 weeks
    • ≥28 days and <12 weeks (patients will receive a maximum of one dose of gemtuzumab ozogamicin)
  • Normal renal function, defined as calculated creatinine clearance ≥90 ml/min/1.73m2
  • Normal hepatic function, defined as total bilirubin ≤2.5 upper limit of normal (ULN) for age and not due to leukaemic involvement or Gilbert's syndrome or similar disorder
  • ALT or AST ≤10 x ULN for age
  • Written informed consent from the patient and/or parent/legal guardian

Inclusion criteria for participation in R2.(once open to randomisation in the applicable age group)

• Patient meets the inclusion criteria for trial entry

Patient age:

  • ≥12 months
  • ≥12 weeks (once R2 open in patients aged ≥12 weeks and <12 months)
  • Normal renal function defined as calculated creatinine clearance ≥90ml/min/1.73m2.
  • Normal hepatic function defined as total bilirubin ≤2.5 ULN for age and not due to leukaemic involvement or Gilbert's syndrome or similar disorder.
  • ALT or AST ≤10 x ULN for age.
  • Written informed consent from the patient and/or parent/legal guardian.

Inclusion criteria for participation in R3.

  • Patient meets the inclusion criteria for trial entry
  • Induction treatment as per MyeChild 01 protocol or treated with 2 courses of mitoxantrone & cytarabine off trial.
  • Minimal residual disease (MRD) response (performed in MyeChild 01 centralised laboratories, see national MyeChild 01 Laboratory Manual):

    • Patients with good risk cytogenetics/molecular genetics and a MRD level <0.1% by flow after course 2, or a decrease in transcript levels of >3 logs after course 2 for those with an informative molecular marker, but without an informative marker of sufficient sensitivity for flow MRD monitoring or
    • Patients with intermediate risk cytogenetics/molecular genetics with a MRD level <0.1% by flow after course 1 and course 2, or a decrease in transcript levels of >3 logs after course 1 and course 2 for those with an informative molecular marker, but without an informative marker of sufficient sensitivity for flow MRD monitoring.
  • Written informed consent from the patient and/or parent/legal guardian.

Inclusion criteria for participation in R4.

  • Patient meets the inclusion criteria for trial entry
  • Induction treatment as per MyeChild 01 protocol or treated with 1 or 2 courses of mitoxantrone & cytarabine ± treatment intensification with fludarabine, cytarabine & idarubicin (FLA-Ida) off trial.
  • Patient is in complete remission (CR) or CR with incomplete blood count recovery (CRi) defined as <5% blasts confirmed by flow cytometry/ molecular/FISH in a bone marrow aspirate taken within 6 weeks prior to randomisation to R4.
  • Patient meets one of the following criteria and is a candidate for HSCT as per the protocol:

    • High risk after course 1 (all patients with poor risk cytogenetics and patients with intermediate risk cytogenetics who fail to achieve CR/CRi).
    • Intermediate risk cytogenetics with MRD >0.1% after course 1 and 2 measured by flow. If no flow MRD marker of sufficient sensitivity is identified, a molecular MRD marker with a sensitivity of >0.1% may be used.
    • Good risk cytogenetics with flow MRD >0.1% confirmed by a decrease in molecular MRD of <3 logs or rising transcript levels after course 3 despite treatment intensification (FLA-Ida) and after discussion with the Clinical Co-ordinators.
  • Availability of a 9-10/10 human leukocyte antigen (HLA) matched family or unrelated donor or 5-8/8 matched cord blood unit with an adequate cell dose as defined by the protocol section 17.1.
  • Written informed consent from the patient and/or parent/legal guardian.

Exclusion

Exclusion criteria for all randomisations

  • Acute Promyelocytic Leukaemia.
  • Myeloid Leukaemia of Down Syndrome.
  • Blast crisis of chronic myeloid leukaemia.
  • Relapsed or refractory AML.
  • Bone marrow failure syndromes.
  • Prior anthracycline exposure which would inhibit the delivery of study anthracyclines.
  • Concurrent treatment or administration of any other experimental drug or with any other biological therapy for AML/high risk MDS/isolated MS.
  • Pregnant or lactating females.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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