Actively Recruiting
International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia
Led by University of Birmingham · Updated on 2021-10-08
700
Participants Needed
68
Research Sites
869 weeks
Total Duration
On this page
Sponsors
U
University of Birmingham
Lead Sponsor
A
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. (Randomisation 1 (R1) closed early to recruitment on 8th September 2017, due to liposomal daunorubicin manufacturing issues resulting in unavailability of the drug.) 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.
CONDITIONS
Official Title
International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute myeloid leukaemia, high risk myelodysplastic syndrome (>10% blasts in bone marrow), or isolated myeloid sarcoma (de novo or secondary)
- Age less than 18 years at trial entry
- No prior chemotherapy or biological therapy for these conditions except as allowed by the protocol
- Normal cardiac function (fractional shortening ≥28% or ejection fraction ≥55%)
- Fit for protocol chemotherapy
- Negative pregnancy test for females of childbearing potential
- Agreement to use effective contraception (if applicable)
- Written informed consent from patient and/or parent or legal guardian
- For gemtuzumab ozogamicin dose finding study: patients must be ≥12 months for major study, or ≥12 weeks and <12 months for minor study
- Normal renal function (creatinine clearance ≥90 ml/min/1.73m²)
- Normal liver function (total bilirubin ≤2.5 times upper limit of normal for age unless due to leukaemic involvement or Gilbert's syndrome)
- ALT or AST ≤10 times upper limit of normal for age
- For R2 participation: meet trial entry criteria, be ≥12 months or ≥12 weeks (once open), with normal renal and hepatic function
- For R3 participation: meet trial entry criteria, received induction treatment per protocol or off trial with mitoxantrone and cytarabine, with specific minimal residual disease response criteria
- For R4 participation: meet trial entry criteria, completed induction treatment per protocol or off trial, in complete remission or CR with incomplete blood count recovery, meet stem cell transplant candidacy criteria including donor availability
You will not qualify if you...
- 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 that would prevent study anthracycline delivery
- Concurrent treatment with other experimental drugs or biological therapies for AML/high risk MDS/isolated MS
- Pregnant or lactating females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 68 locations
1
Women and Children's Hospital Adelaide
Adelaide, Australia
Actively Recruiting
2
Queensland Children's Hospital
Brisbane, Australia
Actively Recruiting
3
Monash Children's Hospital
Melbourne, Australia
Actively Recruiting
4
Royal Childrens Hospital
Melbourne, Australia
Actively Recruiting
5
John Hunter Children's Hopsital
New Lambton Heights, Australia
Actively Recruiting
6
Perth Children's Hospital
Perth, Australia
Actively Recruiting
7
Sydney Children's Hospital
Sydney, Australia
Actively Recruiting
8
The Childrens Hospital At Westmead
Westmead, Australia
Actively Recruiting
9
Centre Hospitalier Universitaire Amiens - Picardie
Amiens, France
Actively Recruiting
10
Centre Hospitalier Universitaire D'angers
Angers, France
Actively Recruiting
11
Centre Hospitalier Regional Universitaire Besancon - Hopital Jean Minjoz
Besançon, France
Actively Recruiting
12
Centre Hospitalier Universitaire De Bordeaux - Hopital Pellegrin
Bordeaux, France
Actively Recruiting
13
Centre Hospitalier Regional Universitaire Brest - Hopital Morvan
Brest, France
Actively Recruiting
14
Centre Hospitalier Universitaire De Caen
Caen, France
Actively Recruiting
15
Centre Hospitalier Universitaire De Clermont-ferrand
Clermont-Ferrand, France
Actively Recruiting
16
Centre Hospitalier Universitaire Dijon Bourgogne - Hopital D'enfants
Dijon, France
Actively Recruiting
17
Centre Hospitalier Universitaire De Grenoble
Grenoble, France
Actively Recruiting
18
Hopital Jeanne Dr Flandre
Lille, France
Actively Recruiting
19
Centre Hospitalier Universitaire De Limoges
Limoges, France
Actively Recruiting
20
Centre Leon Berard
Lyon, France
Actively Recruiting
21
Hopital De La Timone
Marseille, France
Actively Recruiting
22
Centre Hospitalier Regional Universitaire Montpellier - Hopital Arnaud-de-villeneuve
Montpellier, France
Actively Recruiting
23
Centre Hospitalier Universitaire De Nancy
Nancy, France
Actively Recruiting
24
Centre Hospitalier Universitaire De Nantes
Nantes, France
Actively Recruiting
25
Centre Hospitalier Universitaire De NICE
Nice, France
Actively Recruiting
26
Hopital Armand Trousseau
Paris, France
Actively Recruiting
27
Hopital Robert Debre
Paris, France
Actively Recruiting
28
Hopital Saint Louis
Paris, France
Actively Recruiting
29
Centre Hospitalier Universitaire De Poitiers
Poitiers, France
Actively Recruiting
30
Chu De Reims
Reims, France
Actively Recruiting
31
Centre Hospitalier Universitaire De Rennes - Hopital Sud
Rennes, France
Actively Recruiting
32
Centre Hospitalier Universitaire De Rouen
Rouen, France
Actively Recruiting
33
Centre Hospitalier Universitaire Saint-etienne
Saint-Etienne, France
Actively Recruiting
34
Strasbourg Hautepierre
Strasbourg, France
Actively Recruiting
35
Centre Hospitalier Universitaire De Toulouse - Hopital Des Enfants
Toulouse, France
Actively Recruiting
36
Centre Hospitalier Regional Universitaire De Tours - Hopital Clocheville
Tours, France
Actively Recruiting
37
Our Lady's Hospital for Sick Children
Dublin, Ireland
Actively Recruiting
38
Starship Childrens Hospital
Auckland, New Zealand
Actively Recruiting
39
Christchurch Hospital
Christchurch, New Zealand
Actively Recruiting
40
Kantonsspital Aarau
Aarau, Switzerland
Actively Recruiting
41
Universitäts-Kinderspital beider
Basel, Switzerland
Actively Recruiting
42
Ospedale San Giovanni
Bellinzona, Switzerland
Actively Recruiting
43
Inselspital Bern
Bern, Switzerland
Actively Recruiting
44
Hug Hopitaux Universitaires De Geneve
Geneva, Switzerland
Actively Recruiting
45
Centre Hospitalier Universitaire Vaudois Chuv Lausanne
Lausanne, Switzerland
Actively Recruiting
46
Luzerner Kantonspital - Kinderspital Luzern
Lucerne, Switzerland
Actively Recruiting
47
Ostschweizer Kinderspital
Sankt Gallen, Switzerland
Actively Recruiting
48
University Children's Hospital Zurich
Zurich, Switzerland
Actively Recruiting
49
Royal Belfast Hospital for Sick Children
Belfast, County Antrim, United Kingdom, BT12 6BE
Actively Recruiting
50
Royal Aberdeen Children's Hospital
Aberdeen, United Kingdom, AB25 2ZG
Actively Recruiting
51
Aberdeen Royal Infirmary, NHS Grampian
Aberdeen, United Kingdom, AB25 2ZN
Actively Recruiting
52
Birmingham Children's Hospital NHS Foundation Trust
Birmingham, United Kingdom, B4 6NH
Actively Recruiting
53
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom, BS1 3NU
Actively Recruiting
54
Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
55
Cardiff and Vale University Health Board, Noah's Ark Children's Hospital for Wales
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
56
NHS Lothian, Royal Hospital for Sick Children
Edinburgh, United Kingdom, EH9 1LF
Actively Recruiting
57
NHS Greater Glasgow and Clyde, The Royal Hospital for Children
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
58
Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
59
Alder Hey Children's NHS Foundation Trust
Liverpool, United Kingdom, L12 2AP
Actively Recruiting
60
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2PG
Actively Recruiting
61
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
62
Great Ormond Street Hospital For Children NHS Trust
London, United Kingdom, WC1N 3JH
Actively Recruiting
63
Royal Manchester Childrens' Hospital , Central Manchester University Hospitals NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
Actively Recruiting
64
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom, NE7 7DN
Actively Recruiting
65
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG7 2UH
Actively Recruiting
66
John Radcliffe Hospital, Oxford Radcliffe Hospitals NHS Trust
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
67
Sheffield Children's NHS Foundation Trust
Sheffield, United Kingdom, S10 2TH
Actively Recruiting
68
Southampton University Hospitals NHS Trust
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
C
Christina Ryan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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