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Childhood leukaemia trial seeks best chemo cocktail

NCT ID NCT02724163

Disease control Sponsor: University of Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This trial investigates the best way to treat children with acute myeloid leukaemia (AML) by comparing different chemotherapy drugs and doses. It tests whether adding up to three doses of the targeted drug gemtuzumab ozogamicin to standard chemo is safe and effective. The study also compares two types of chemotherapy for induction and two different conditioning regimens for stem cell transplants. Around 700 children under 18 with AML or related conditions are taking part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Gemtuzumab ozogamicin (Mylotarg), liposomal daunorubicin, mitoxantrone, cytarabine, fludarabine, busulfan, cyclophosphamide
What this could lead to
If successful, this could identify safer, more effective chemotherapy and antibody-drug combinations for children with AML, potentially improving survival and reducing side effects.
What could go wrong
This is a large phase 3 trial, but some drug combinations were dropped early due to manufacturing issues. Results may not apply to all AML subtypes, and side effects from intensive chemo remain significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2016

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 Criteria: 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.

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Conditions

The condition(s) this trial relates to.

acute myeloblastic leukemia with maturation acute myeloid leukemia myelodysplastic syndrome myeloid sarcoma Neoplasm, Residual

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukaemia

Contacts and locations

Locations

  • Aberdeen Royal Infirmary, NHS Grampian

    Aberdeen, AB25 2ZN, United Kingdom

  • Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ, United Kingdom

  • Alder Hey Children's NHS Foundation Trust

    Liverpool, L12 2AP, United Kingdom

  • Birmingham Children's Hospital NHS Foundation Trust

    Birmingham, B4 6NH, United Kingdom

  • Cardiff and Vale University Health Board, Noah's Ark Children's Hospital for Wales

    Cardiff, CF14 4XW, United Kingdom

  • Centre Hospitalier Regional Universitaire Besancon - Hopital Jean Minjoz

    Besançon, France

  • Centre Hospitalier Regional Universitaire Brest - Hopital Morvan

    Brest, France

  • Centre Hospitalier Regional Universitaire De Tours - Hopital Clocheville

    Tours, France

  • Centre Hospitalier Regional Universitaire Montpellier - Hopital Arnaud-de-villeneuve

    Montpellier, France

  • Centre Hospitalier Universitaire Amiens - Picardie

    Amiens, France

  • Centre Hospitalier Universitaire D'angers

    Angers, France

  • Centre Hospitalier Universitaire De Bordeaux - Hopital Pellegrin

    Bordeaux, France

  • Centre Hospitalier Universitaire De Caen

    Caen, France

  • Centre Hospitalier Universitaire De Clermont-ferrand

    Clermont-Ferrand, France

  • Centre Hospitalier Universitaire De Grenoble

    Grenoble, France

  • Centre Hospitalier Universitaire De Limoges

    Limoges, France

  • Centre Hospitalier Universitaire De NICE

    Nice, France

  • Centre Hospitalier Universitaire De Nancy

    Nancy, France

  • Centre Hospitalier Universitaire De Nantes

    Nantes, France

  • Centre Hospitalier Universitaire De Poitiers

    Poitiers, France

  • Centre Hospitalier Universitaire De Rennes - Hopital Sud

    Rennes, France

  • Centre Hospitalier Universitaire De Rouen

    Rouen, France

  • Centre Hospitalier Universitaire De Toulouse - Hopital Des Enfants

    Toulouse, France

  • Centre Hospitalier Universitaire Dijon Bourgogne - Hopital D'enfants

    Dijon, France

  • Centre Hospitalier Universitaire Saint-etienne

    Saint-Etienne, France

  • Centre Hospitalier Universitaire Vaudois Chuv Lausanne

    Lausanne, Switzerland

  • Centre Leon Berard

    Lyon, France

  • Christchurch Hospital

    Christchurch, New Zealand

  • Chu De Reims

    Reims, France

  • Great Ormond Street Hospital For Children NHS Trust

    London, WC1N 3JH, United Kingdom

  • Hopital Armand Trousseau

    Paris, France

  • Hopital De La Timone

    Marseille, France

  • Hopital Jeanne Dr Flandre

    Lille, France

  • Hopital Robert Debre

    Paris, France

  • Hopital Saint Louis

    Paris, France

  • Hug Hopitaux Universitaires De Geneve

    Geneva, Switzerland

  • Inselspital Bern

    Bern, Switzerland

  • John Hunter Children's Hopsital

    New Lambton Heights, Australia

  • John Radcliffe Hospital, Oxford Radcliffe Hospitals NHS Trust

    Oxford, OX3 9DU, United Kingdom

  • Kantonsspital Aarau

    Aarau, Switzerland

  • Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF, United Kingdom

  • Luzerner Kantonspital - Kinderspital Luzern

    Lucerne, Switzerland

  • Monash Children's Hospital

    Melbourne, Australia

  • NHS Greater Glasgow and Clyde, The Royal Hospital for Children

    Glasgow, G51 4TF, United Kingdom

  • NHS Lothian, Royal Hospital for Sick Children

    Edinburgh, EH9 1LF, United Kingdom

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH, United Kingdom

  • Ospedale San Giovanni

    Bellinzona, Switzerland

  • Ostschweizer Kinderspital

    Sankt Gallen, Switzerland

  • Our Lady's Hospital for Sick Children

    Dublin, Ireland

  • Perth Children's Hospital

    Perth, Australia

  • Queensland Children's Hospital

    Brisbane, Australia

  • Royal Aberdeen Children's Hospital

    Aberdeen, AB25 2ZG, United Kingdom

  • Royal Belfast Hospital for Sick Children

    Belfast, County Antrim, BT12 6BE, United Kingdom

  • Royal Childrens Hospital

    Melbourne, Australia

  • Royal Manchester Childrens' Hospital , Central Manchester University Hospitals NHS Foundation Trust

    Manchester, M13 9WL, United Kingdom

  • Sheffield Children's NHS Foundation Trust

    Sheffield, S10 2TH, United Kingdom

  • Southampton University Hospitals NHS Trust

    Southampton, SO16 6YD, United Kingdom

  • Starship Childrens Hospital

    Auckland, New Zealand

  • Strasbourg Hautepierre

    Strasbourg, France

  • Sydney Children's Hospital

    Sydney, Australia

  • The Childrens Hospital At Westmead

    Westmead, Australia

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle, NE7 7DN, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ, United Kingdom

  • University Children's Hospital Zurich

    Zurich, Switzerland

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG, United Kingdom

  • University Hospitals Bristol NHS Foundation Trust

    Bristol, BS1 3NU, United Kingdom

  • Universitäts-Kinderspital beider

    Basel, Switzerland

  • Women and Children's Hospital Adelaide

    Adelaide, Australia

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