Last updated on May 2017

International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia


Brief description of study

The main purpose of this study is : 1. To establish which number of doses of gemtuzumab ozogamicin (up to a maximum of 3 doses) is tolerated and can be safety delivered in combination with cytarabine plus mitoxantrone or liposomal daunorubicin in induction 2. To compare mitoxantrone (anthracenedione) & cytarabine with liposomal daunorubicin (anthracycline) & cytarabine as induction therapy. 3. To compare a single dose of gemtuzumab ozogamicin with the optimum tolerated number of doses of gemtuzumab ozogamicin (identified by the dose-finding study) when combined with induction chemotherapy. 4. To compare two consolidation regimens: high dose cytarabine (HD Ara-C) and fludarabine & cytarabine (FLA) in standard risk patients. 5. To compare the toxicity and effectiveness of two haemopoietic stem cell transplant (HSCT) conditioning regimens of different intensity: conventional myeloablative conditioning (MAC) with busulfan/cyclophosphamide and reduced intensity conditioning (RIC) with fludarabine/busulfan.

Detailed Study Description

MyeChild 01 is an international phase III clinical trial in children with acute myeloid leukaemia (AML); a disease with significant mortality. It will compare two induction chemotherapy regimens: mitoxantrone and cytarabine (current standard treatment) with liposomal daunorubicin and cytarabine. This will test liposomal daunorubicin, which is believed to be less cardiotoxic than similar conventional drugs, although this is unproven. 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). HSCT has not consistently shown benefit in high risk patients because the mortality associated with the procedure has outweighed the advantage from a reduction in relapse risk. This will test whether reducing the intensity of conditioning improves survival by reducing transplant related deaths without increasing the relapse rate. The trial incorporates a dose finding study for gemtuzumab ozogamicin. The aim is to identify the optimum tolerated number of doses of gemtuzumab ozogamicin (up to a total of 3 doses), which can be safely combined with either of the induction chemotherapy regimens and then to compare this number of doses with one dose of gemtuzumab ozogamicin. The intensity of treatment will be directed by cytogenetics/molecular genetics and response assessed by minimal residual disease (MRD) levels measured by flow cytometry and molecular methodology.

Clinical Study Identifier: NCT02724163

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Colin McAlister

Aberdeen Royal Infirmary, NHS Grampian
Aberdeen, United Kingdom
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Colin McAlister

Belfast City Hospital, Belfast Health and Social Care Trust
Belfast, United Kingdom
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Colin McAlister

Birmingham Children's Hospital NHS Foundation Trust
Birmingham, United Kingdom
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Colin McAlister

University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom
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Colin McAlister

Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
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Colin McAlister

Cardiff and Vale University Health Board, Noah's Ark Children's Hospital for Wales
Cardiff, United Kingdom
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Colin McAlister

NHS Lothian, Royal Hospital for Sick Children
Edinburgh, United Kingdom
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Colin McAlister

NHS Greater Glasgow and Clyde, The Royal Hospital for Children
Glasgow, United Kingdom
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Colin McAlister

Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
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Colin McAlister

Alder Hey Children's NHS Foundation Trust
Liverpool, United Kingdom
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Colin McAlister

University College London Hospitals NHS Foundation Trust
London, United Kingdom
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Colin McAlister

The Royal Marsden NHS Foundation Trust
London, United Kingdom
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Colin McAlister

Great Ormond Street Hospital For Children NHS Trust
London, United Kingdom
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Colin McAlister

Royal Manchester Childrens' Hospital , Central Manchester University Hospitals NHS Foundation Trust
Manchester, United Kingdom
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Colin McAlister

The Christie NHS Foundation
Manchester, United Kingdom
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Colin McAlister

The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom
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Colin McAlister

Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
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Colin McAlister

John Radcliffe Hospital, Oxford Radcliffe Hospitals NHS Trust
Oxford, United Kingdom
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Colin McAlister

Sheffield Children's NHS Foundation Trust
Sheffield, United Kingdom
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Colin McAlister

Southampton University Hospitals NHS Trust
Southampton, United Kingdom
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