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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02724163
Additional trial details provided through ANZCTR are available at the end of this record.
Registration number
NCT02724163
Ethics application status
Date submitted
8/01/2016
Date registered
31/03/2016
Titles & IDs
Public title
International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia
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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
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Secondary ID [1]
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2014-005066-30
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Secondary ID [2]
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RG_14-088
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Universal Trial Number (UTN)
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Trial acronym
Myechild01
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukaemia
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Condition category
Condition code
Cancer
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0
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Leukaemia - Acute leukaemia
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Cancer
0
0
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0
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Leukaemia - Chronic leukaemia
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Cancer
0
0
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0
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Gemtuzumab ozogamicin
Treatment: Drugs - Liposomal daunorubicin
Treatment: Drugs - Mitoxantrone
Treatment: Drugs - Fludarabine
Treatment: Drugs - Cytarabine
Treatment: Drugs - Busulfan
Treatment: Drugs - Cyclophosphamide
Active comparator: Mitoxantrone - Course 1
* Mitoxantrone: 12 mg/m2 daily by IV infusion over 1 hour on days 1, 2, 3 and 4 (total 4 doses).
* Cytarabine:100 mg/m2 12 hourly by IV bolus on days 1-10 inclusive (total 20 doses).
Course 2
* Mitoxantrone: 12 mg/m2 daily by IV infusion over 1 hour on days 1, 2 and 3 (total 3 doses).
* Cytarabine: 100 mg/m2 12 hourly by IV bolus on days 1-8 inclusive (total 16 doses).
Experimental: Liposomal daunorubicin - Randomisation 1 (R1)) closed early to recruitment on 8th September 2017, due to liposomal daunorubicin manufacturing issues resulting in unavailability of the drug.
Course 1
* Liposomal daunorubicin: 80 mg/m2 daily by 1 hour IV infusion on days 1, 3 and 5 (total 3 doses).
* Cytarabine: 100 mg/m2 12 hourly by IV bolus on days 1-10 inclusive (total 20 doses).
Course 2
* Liposomal daunorubicin: 60 mg/m2 daily by 1 hour IV infusion on days 1, 3 and 5 (total 3 doses).
* Cytarabine: 100 mg/m2 12 hourly by IV bolus on days 1-8 inclusive (total 16 doses).
Experimental: Gemtuzumab Ozogamicin Dose Finding Study - * Cohort 1: 1x3mg/m2 IV infusion over 2hours on day 4.
* Cohort 2: 2x3mg/m2 IV infusion over 2hours on day 4 and day 7.
* Cohort 3: 3x3mg/m2 IV infusion over 2hours on days 4, 7 and 10.
Active comparator: High dose cytarabine - Two courses of Cytarabine: 3 g/m2 12 hourly by IV infusion over 4 hours on days 1, 3 and 5 (total 6 doses).
Experimental: Fludarabine & cytarabine - Two courses of:
* Fludarabine: 30 mg/m2 daily by IV infusion over 30 minutes on days 1-5 inclusive (total 5 doses).
* Cytarabine: 2 g/m2 daily by IV infusion over 4 hours on days 1-5 inclusive (total 5 doses).The cytarabine infusion should be started 4 hours after the start of the fludarabine infusion
Active comparator: Myeloablative conditioning - * Busulfan Area Under the Curve (AUC) 70-100mg/L x hr by IV infusion over 3 hours, given 12 hourly on days -10 to -7 (8 doses).
* Cyclophosphamide 50mg/kg/day by IV infusion over 1 hour, on days -5 to -2 (4 doses).
Experimental: Reduced intensity conditioning - * Busulfan AUC60-65mg/L X hr by IV infusion over 3 hours, given 12 hourly on days -5 to -2 (8 doses).
* Fludarabine 30mg/m2/day by IV infusion over 30 minutes on days -8 to -3 (6 doses).
Treatment: Drugs: Gemtuzumab ozogamicin
Antibody-conjugated chemotherapy agent.
Treatment: Drugs: Liposomal daunorubicin
Anthracycline
(Randomisation 1 (R1)) closed early to recruitment on 8th September 2017, due to liposomal daunorubicin manufacturing issues resulting in unavailability of the drug.
Treatment: Drugs: Mitoxantrone
DNA-reactive agent
Treatment: Drugs: Fludarabine
A water-soluble fluorinated nucleotide analogue of the antiviral agent vidarabine.
Treatment: Drugs: Cytarabine
Pyrimidine nucleoside analogue, an antineoplastic agent.
Treatment: Drugs: Busulfan
Alkylsulfonate
Treatment: Drugs: Cyclophosphamide
A nitrogen mustard alkylating agent from the oxazaphosphorine group
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of dose limiting toxicities (DLTs).
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Assessment method [1]
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Timepoint [1]
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Incidence of DLTs will be evaluated up to day 45 post course 1 and course 2 of induction chemotherapy.
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Primary outcome [2]
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Event Free Survival (EFS).
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Assessment method [2]
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The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. EFS estimates will be presented at 24 months along with 95% confidence intervals.
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Timepoint [2]
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Event free survival (EFS) will be evaluated as the time from randomisation one to the first event, up to 16 years.
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Primary outcome [3]
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Event Free Survival (EFS).
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Assessment method [3]
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The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. EFS estimates will be presented at 24 months along with 95% confidence intervals.
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Timepoint [3]
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Event free survival (EFS) will be evaluated as the time from randomisation two to the first event, up to 16 years..
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Primary outcome [4]
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Relapse free survival (RFS).
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Assessment method [4]
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The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. RFS estimates will be presented at 24 months along with 95% confidence intervals.
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Timepoint [4]
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Relapse free survival (RFS) will be evaluated as the time of randomisation three to the first relapse or death from any cause, up to 16 years.
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Primary outcome [5]
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Early treatment related adverse reactions.
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Assessment method [5]
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Early treatment related adverse reactions defined as the incidence by day 100 post-transplant of grade 3-5 toxicity for the following systems using the National Cancer Institute (NCI) Common Terminology Criteria v4:
* Cardiac (pericardial effusion/Left ventricular systolic dysfunction).
* Respiratory, thoracic and mediastinal (hypoxia/pneumonitis).
* Gastrointestinal (GI) (diarrhoea/typhlitis/upper and lower GI haemorrhage).
* Investigations (bilirubin).
* Renal and Urinary (acute kidney injury/haematuria).
* Nervous system (seizure).
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Timepoint [5]
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Early treatment related adverse reactions will be evaluated at day 100 post-transplant.
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Primary outcome [6]
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Relapse free survival (RFS).
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Assessment method [6]
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The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. RFS estimates will be presented at 12 months along with 95% confidence intervals.
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Timepoint [6]
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Relapse free survival (RFS) will be evaluated as the time of randomisation four to the first relapse or death from any cause, up to 16 years.
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Secondary outcome [1]
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The nature, incidence and severity of adverse events (AEs) (gemtuzumab ozogamicin dose finding study).
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Assessment method [1]
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Timepoint [1]
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Evaluated by day 45 post course 1 and course 2.
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Secondary outcome [2]
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Response measured by bone marrow assessment using morphology and minimal residual disease (MRD) assessment (gemtuzumab ozogamicin dose finding study).
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Assessment method [2]
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Response is assessed by morphology confirmed by MRD levels measured by flow cytometry, molecular methods or fluorescence in situ hybridisation (FISH) as defined in the protocol, in combination with platelet and neutrophil counts. These results of these assessments will be combined to determine the patient's disease response using the response criteria defined in the protocol.
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Timepoint [2]
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Evaluated by day 45 post course 1 and course 2.
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Secondary outcome [3]
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Serum pharmacokinetic (PK) parameters of gemtuzumab ozogamicin: Clearance (CL) (gemtuzumab ozogamicin dose finding study)
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Assessment method [3]
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Serum PK parameters will be measured using serial samples taken at multiple timepoints during course 1 and at 1 month post first dose of gemtuzumab ozogamicin as defined in the protocol by dose cohort.
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Timepoint [3]
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Evaluated up to one month after the first dose of gemtuzumab ozogamicin.
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Secondary outcome [4]
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Serum pharmacokinetic (PK) parameters of gemtuzumab ozogamicin: Volume of distribution (Vd) (gemtuzumab ozogamicin dose finding study)
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Assessment method [4]
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Serum PK parameters will be measured using serial samples taken at multiple timepoints during course 1 and at 1 month post first dose of gemtuzumab ozogamicin as defined in the protocol by dose cohort.
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Timepoint [4]
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Evaluated up to one month after the first dose of gemtuzumab ozogamicin.
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Secondary outcome [5]
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Complete remission (CR) (R1 & R2).
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Assessment method [5]
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Evaluated using remission status at completion of course 1 and course 2.
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Timepoint [5]
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Evaluated and presented at the completion of course 1 and 2 of treatment up to a maximum of 45 days post each course of treatment
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Secondary outcome [6]
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Reasons for failure to achieve CR (R1 & R2).
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Assessment method [6]
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Evaluated as resistant disease, induction death or not evaluable.This will be evaluated at completion of course 1 and 2 of treatment, once patient's blood counts have recovered or reason for non-recovery has been determined.
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Timepoint [6]
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Evaluated and presented at the completion of course 1 and 2 of treatment, up to a maximum of 45 days post each course of treatment.
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Secondary outcome [7]
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Cumulative Incidence of Relapse (CIR) (all randomisations).
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Assessment method [7]
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The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. CIR estimates will be presented at 24 months along with 95% confidence intervals for randomisations 1, 2 and 3, and at 12 months for randomisation 4.
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Timepoint [7]
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Evaluated as time from randomisation to the relevant question to relapse, up to 16 years.
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Secondary outcome [8]
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Death in CR (DCR) (R1, R2 & R3).
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Assessment method [8]
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The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. DCR estimates will be presented at 24 months along with 95% confidence intervals.
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Timepoint [8]
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Evaluated as time from randomisation to relevant question to date of death from any cause in patients who have achieved CR, up to 16 years.
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Secondary outcome [9]
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Event Free Survival (EFS) (R1, R2 & R3).
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Assessment method [9]
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The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. EFS estimates will be presented at 24 months along with 95% confidence intervals.
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Timepoint [9]
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Evaluated as time from randomisation to the relevant question to the first of failure to achieve CR (recorded as an event on day 1), relapse, secondary malignancy or death from any cause, up to 16 years.
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Secondary outcome [10]
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Overall Survival (OS) (all randomisations).
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Assessment method [10]
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The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. OS estimates will be presented at 24 months along with 95% confidence intervals for randomisations 1, 2 and 3, and at 12 months for randomisation 4.
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Timepoint [10]
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Evaluated as time from randomisation to the relevant question to death from any cause or date last seen for patients who are alive at the end of the trial, up to 16 years.
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Secondary outcome [11]
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Incidence of toxicities (all randomisations).
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Assessment method [11]
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Timepoint [11]
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Evaluated 30 days after end of trial treatment.
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Secondary outcome [12]
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Incidence of cardiotoxicity (R1, R2 & R4 only).
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Assessment method [12]
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0
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Timepoint [12]
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Evaluated 30 days after end of trial treatment.
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Secondary outcome [13]
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Incidence of bilirubin of grade 3 of higher (R2 & R4 only).
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Assessment method [13]
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0
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Timepoint [13]
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Evaluated 30 days after end of trial treatment.
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Secondary outcome [14]
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Incidence of Veno-Occlusive Disease (R2 & R4 only).
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Assessment method [14]
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0
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Timepoint [14]
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Evaluated 30 days after end of trial treatment.
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Secondary outcome [15]
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Minimal Residual Disease (MRD) clearance after course 1 & 2 (R1 & R2 only).
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Assessment method [15]
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Evaluated using MRD result at completion of course 1 and 2 once patient's blood counts have recovered or reason for non-recovery has been determined.
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Timepoint [15]
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Evaluated and presented at completion of course 1 and 2 of treatment, up to a maximum of 45 days post each course of treatment.
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Secondary outcome [16]
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Time to haematological recovery (all randomisations).
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Assessment method [16]
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Evaluated using the date of haematological recovery (platelets to \>=80 x 10\^9/L, and neutrophils to \>=1.0 x 10\^9/L). The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. Time to haematological recovery estimates will be presented at 45 days post course 1 and course 2 of treatment along with 95% confidence intervals.
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Timepoint [16]
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Evaluated by day 45 post course 1 and course 2.
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Secondary outcome [17]
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Days in hospital after each course of treatment (all randomisations).
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Assessment method [17]
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Total number of days spent in hospital for each course of treatment, collected from date of randomisation until count recovery after final course of treatment, up to a maximum of 45 days post the final course of treatment. This will be summarised per course of treatment.
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Timepoint [17]
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Evaluated once all patients have completed trial treatment.
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Secondary outcome [18]
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Incidence of mixed chimerism at day 100 post-transplant (R4 only).
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Assessment method [18]
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Timepoint [18]
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Evaluated at day 100 post-transplant.
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Secondary outcome [19]
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Treatment Related Mortality (TRM) (R4 only).
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Assessment method [19]
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The primary analysis will be carried out once the last patient has a minimum of 1 year follow up which is estimated to be 7 years after the start of recruitment. TRM estimates will be presented at 12 months along with 95% confidence intervals.
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Timepoint [19]
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Evaluated as time in days between randomisation to R4 and death which is unrelated to the underlying disease and considered related to the transplant procedure.
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Secondary outcome [20]
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Gonadal function (R4 only).
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Assessment method [20]
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The method of assessment will be by scale (Tanner scale) and physiological parameters. This will be evaluated at 1 year post-transplant and at the end of study follow-up.
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Timepoint [20]
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Evaluated at 1 year post-transplant and at the end of follow-up, which is estimated to be through to study completion, an average timeframe of 10 years.
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Eligibility
Key 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.
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Minimum age
No limit
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2032
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Actual
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Sample size
Target
700
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Women and Children's Hospital Adelaide - Adelaide
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Recruitment hospital [2]
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Queensland Children's Hospital - Brisbane
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Recruitment hospital [3]
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Monash Children's Hospital - Melbourne
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Recruitment hospital [4]
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Royal Childrens Hospital - Melbourne
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Recruitment hospital [5]
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John Hunter Children's Hopsital - New Lambton Heights
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Recruitment hospital [6]
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Perth Children's Hospital - Perth
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Recruitment hospital [7]
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Sydney Children's Hospital - Sydney
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Recruitment hospital [8]
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0
The Childrens Hospital At Westmead - Westmead
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Brisbane
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Recruitment postcode(s) [3]
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0
- Melbourne
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Recruitment postcode(s) [4]
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- New Lambton Heights
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Recruitment postcode(s) [5]
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0
- Perth
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Recruitment postcode(s) [6]
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0
- Sydney
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Recruitment postcode(s) [7]
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- Westmead
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Recruitment outside Australia
Country [1]
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0
France
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State/province [1]
0
0
Amiens
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Country [2]
0
0
France
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State/province [2]
0
0
Angers
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Country [3]
0
0
France
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State/province [3]
0
0
Besançon
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Country [4]
0
0
France
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State/province [4]
0
0
Bordeaux
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Country [5]
0
0
France
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State/province [5]
0
0
Brest
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Country [6]
0
0
France
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State/province [6]
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0
Caen
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Country [7]
0
0
France
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State/province [7]
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0
Clermont-Ferrand
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Country [8]
0
0
France
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State/province [8]
0
0
Dijon
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Country [9]
0
0
France
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State/province [9]
0
0
Grenoble
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Country [10]
0
0
France
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State/province [10]
0
0
Lille
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Country [11]
0
0
France
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State/province [11]
0
0
Limoges
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Country [12]
0
0
France
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State/province [12]
0
0
Lyon
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Country [13]
0
0
France
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State/province [13]
0
0
Marseille
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Country [14]
0
0
France
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State/province [14]
0
0
Montpellier
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Country [15]
0
0
France
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State/province [15]
0
0
Nancy
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Country [16]
0
0
France
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State/province [16]
0
0
Nantes
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Country [17]
0
0
France
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State/province [17]
0
0
Nice
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Country [18]
0
0
France
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State/province [18]
0
0
Paris
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0
0
France
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0
0
Poitiers
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0
0
France
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0
0
Reims
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0
0
France
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0
0
Rennes
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0
France
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Rouen
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0
France
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Saint-Étienne
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0
0
France
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Strasbourg
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0
0
France
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Toulouse
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France
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0
Tours
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0
Ireland
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Dublin
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0
New Zealand
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Auckland
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New Zealand
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Christchurch
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0
0
Switzerland
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0
Aarau
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0
0
Switzerland
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0
Basel
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0
Switzerland
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0
Bellinzona
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0
0
Switzerland
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Bern
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0
Switzerland
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Geneve
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0
Switzerland
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Lausanne
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0
Switzerland
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Lucerne
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0
Switzerland
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0
St. Gallen
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0
0
Switzerland
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0
Zurich
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0
0
United Kingdom
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0
County Antrim
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0
United Kingdom
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0
Aberdeen
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0
0
United Kingdom
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0
0
Birmingham
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0
United Kingdom
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Bristol
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0
United Kingdom
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Cambridge
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0
United Kingdom
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0
Cardiff
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0
0
United Kingdom
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Edinburgh
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0
United Kingdom
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Glasgow
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United Kingdom
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Leeds
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0
United Kingdom
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Liverpool
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0
United Kingdom
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London
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0
0
United Kingdom
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0
Manchester
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0
0
United Kingdom
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0
Newcastle
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United Kingdom
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0
Nottingham
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0
0
United Kingdom
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0
0
Oxford
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0
0
United Kingdom
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0
0
Sheffield
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Country [55]
0
0
United Kingdom
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State/province [55]
0
0
Southampton
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Birmingham
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Address
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Country
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Other collaborator category [1]
0
0
Other
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Name [1]
0
0
Assistance Publique - Hôpitaux de Paris
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Address [1]
0
0
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Country [1]
0
0
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Other collaborator category [2]
0
0
Other
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Name [2]
0
0
Cancer Research UK
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Address [2]
0
0
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0
0
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Other collaborator category [3]
0
0
Government body
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Name [3]
0
0
National Cancer Institute, France
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Address [3]
0
0
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Country [3]
0
0
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Other collaborator category [4]
0
0
Commercial sector/industry
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Name [4]
0
0
Pfizer
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Address [4]
0
0
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Country [4]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02724163
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Brenda Gibson
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Address
0
0
Royal Hospital for Children Glasgow
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0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Christina Ryan
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Address
0
0
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Country
0
0
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Phone
0
0
01214151049
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02724163
Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC
Recruiting in New Zealand
Province(s)/district(s)
Christchurch Hospital Starship Hospital
Funding & Sponsors
Primary sponsor
Primary sponsor name
Primary sponsor address
Primary sponsor country
Secondary sponsor category [1]
31
Other Collaborative groups
Name [1]
31
ANZCHOG
Address [1]
31
27-31 Wright Street, Clayton VIC 3168
Country [1]
31
Australia
Ethics approval
Ethics application status
Public notes
Children's Hospital Westmead
John Hunter Children's Hospital
Monash Children's Hospital
Perth Children's Hospital
Queensland Children's Hospital
Royal Children's Hospital
Sydney Children's Hospital
Women's and Children's Hospital
Contacts
Principal investigator
Title
153
0
A/Prof
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Name
153
0
Andrew Moore
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Address
153
0
Children’s Health Queensland Hospital and Health Service Centre for Children’s Health Research 62 Graham St, South Brisbane QLD 4101
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Country
153
0
Australia
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Phone
153
0
+617 3069 7593
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Fax
153
0
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Email
153
0
[email protected]
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Contact person for public queries
Title
154
0
Mrs
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Name
154
0
Robyn Strong
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Address
154
0
27-31 Wright Street, Clayton VIC 3168
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Country
154
0
Australia
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Phone
154
0
+613 8572 2684
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Fax
154
0
+613 9902 4810
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Email
154
0
[email protected]
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Contact person for scientific queries
Title
155
0
A/Prof
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Name
155
0
Andrew Moore
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Address
155
0
Children’s Health Queensland Hospital and Health Service Centre for Children’s Health Research 62 Graham St, South Brisbane QLD 4101
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Country
155
0
Australia
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Phone
155
0
+617 3069 7593
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Fax
155
0
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Email
155
0
[email protected]
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