Actively Recruiting
International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia Incorporating a Dose Finding Study for Gemtuzumab Ozogamicin in Combination With Induction Chemotherapy
Led by University of Birmingham · Updated on 2021-10-08
700
Participants Needed
68
Research Sites
52 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
This research focuses on children with acute myeloid leukaemia (AML), a serious blood cancer with significant mortality risk. It aims to determine the safest number of doses of gemtuzumab ozogamicin when combined with standard induction chemotherapy and to compare different chemotherapy regimens, consolidation treatments, and stem cell transplant conditioning intensities. The study includes a dose-finding phase for gemtuzumab ozogamicin and evaluates treatment responses using genetic and minimal residual disease markers. Participants receive induction chemotherapy with either mitoxantrone plus cytarabine or, previously, liposomal daunorubicin plus cytarabine, although the latter arm was closed early due to drug availability issues. Gemtuzumab ozogamicin doses are tested in cohorts receiving one to three doses during induction. After induction, patients may be randomized to receive one of two consolidation regimens: high-dose cytarabine or fludarabine with cytarabine. Those at higher risk may undergo stem cell transplant with either myeloablative or reduced intensity conditioning regimens. During the study, participants undergo various assessments including bone marrow tests, minimal residual disease measurements, and monitoring for treatment side effects and toxicities. Researchers track event-free survival, relapse-free survival, and treatment-related adverse reactions over up to 16 years. Safety is closely monitored especially after transplant, and long-term outcomes such as gonadal function are evaluated. The total participation length varies depending on treatment and follow-up phases.
CONDITIONS
Brief 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 (AML), high risk myelodysplastic syndrome (MDS) with >10% blasts, or isolated myeloid sarcoma (MS), either new or secondary
- Age under 18 years at trial entry
- No prior chemotherapy or biological therapy for AML, high risk MDS, or isolated MS except as allowed in the protocol
- Normal heart function defined by fractional shortening ≥28% or ejection fraction ≥55%
- Fit to receive protocol chemotherapy
- Negative pregnancy test for females of childbearing potential
- Agreement to use effective contraception for patients of childbearing potential
- Written informed consent from patient and/or parent or legal guardian
- For gemtuzumab ozogamicin dose finding study: specific age ranges and normal kidney and liver function as defined
- For participation in consolidation and transplant randomisations: meeting defined disease response and donor availability criteria, with consent
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 exposure to anthracyclines that would prevent study drug use
- Concurrent treatment with other experimental drugs or biological therapies for AML, high risk MDS, or isolated MS
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 to 3 months covering induction and consolidation courses and transplant conditioning where applicable
Participants receive induction chemotherapy with mitoxantrone and cytarabine or liposomal daunorubicin and cytarabine, possibly combined with gemtuzumab ozogamicin in a dose finding study, followed by consolidation chemotherapy or haemopoietic stem cell transplant depending on response and risk factors.
Multiple treatment visits during chemotherapy courses and transplant conditioning
Duration - Up to 16 years
Participants are monitored long-term for event free survival, relapse free survival, treatment related toxicities, and overall health outcomes.
Regular follow-up visits scheduled as per protocol up to 16 years
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
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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