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International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia (Myechild01)

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ClinicalTrials.gov Identifier: NCT02724163
Recruitment Status : Recruiting
First Posted : March 31, 2016
Last Update Posted : October 26, 2017
Sponsor:
Collaborators:
Assistance Publique - Hôpitaux de Paris
Cancer Research UK
National Cancer Institute, France
Pfizer
Information provided by (Responsible Party):
University of Birmingham

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.
  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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukaemia Drug: Gemtuzumab ozogamicin Drug: Liposomal daunorubicin Drug: Mitoxantrone Drug: Fludarabine Drug: Cytarabine Drug: Busulfan Drug: Cyclophosphamide Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2016
Estimated Primary Completion Date : December 2031
Estimated Study Completion Date : December 2032


Arm Intervention/treatment
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).
Drug: Mitoxantrone
DNA-reactive agent
Drug: Cytarabine
Pyrimidine nucleoside analogue, an antineoplastic agent.
Experimental: Liposomal daunorubicin

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).
Drug: Liposomal daunorubicin
Anthracycline
Drug: Cytarabine
Pyrimidine nucleoside analogue, an antineoplastic agent.
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.
Drug: Gemtuzumab ozogamicin
Antibody-conjugated chemotherapy agent.
Other Name: Mylotarg
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).
Drug: Cytarabine
Pyrimidine nucleoside analogue, an antineoplastic agent.
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
Drug: Fludarabine
A water-soluble fluorinated nucleotide analogue of the antiviral agent vidarabine.
Drug: Cytarabine
Pyrimidine nucleoside analogue, an antineoplastic agent.
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).
Drug: Busulfan
Alkylsulfonate
Drug: Cyclophosphamide
A nitrogen mustard alkylating agent from the oxazaphosphorine group
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).
Drug: Fludarabine
A water-soluble fluorinated nucleotide analogue of the antiviral agent vidarabine.
Drug: Busulfan
Alkylsulfonate



Primary Outcome Measures :
  1. Incidence of dose limiting toxicities (DLTs). [ Time Frame: Incidence of DLTs will be evaluated up to day 45 post course 1 and course 2 of induction chemotherapy. ]
  2. Event Free Survival (EFS). [ Time Frame: Event free survival (EFS) will be evaluated as the time from randomisation one to the first event, up to 16 years. ]
    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.

  3. Event Free Survival (EFS). [ Time Frame: Event free survival (EFS) will be evaluated as the time from randomisation two to the first event, up to 16 years.. ]
    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.

  4. Relapse free survival (RFS). [ Time Frame: 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. ]
    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.

  5. Early treatment related adverse reactions. [ Time Frame: Early treatment related adverse reactions will be evaluated at day 100 post-transplant. ]

    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).

  6. Relapse free survival (RFS). [ Time Frame: 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. ]
    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.


Secondary Outcome Measures :
  1. The nature, incidence and severity of adverse events (AEs) (gemtuzumab ozogamicin dose finding study). [ Time Frame: Evaluated by day 45 post course 1 and course 2. ]
  2. Response measured by bone marrow assessment using morphology and minimal residual disease (MRD) assessment (gemtuzumab ozogamicin dose finding study). [ Time Frame: Evaluated by day 45 post course 1 and course 2. ]
    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.

  3. Serum pharmacokinetic (PK) parameters of gemtuzumab ozogamicin: Clearance (CL) (gemtuzumab ozogamicin dose finding study) [ Time Frame: Evaluated up to one month after the first dose of gemtuzumab ozogamicin. ]
    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.

  4. Serum pharmacokinetic (PK) parameters of gemtuzumab ozogamicin: Volume of distribution (Vd) (gemtuzumab ozogamicin dose finding study) [ Time Frame: Evaluated up to one month after the first dose of gemtuzumab ozogamicin. ]
    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.

  5. Complete remission (CR) (R1 & R2). [ Time Frame: 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 ]
    Evaluated using remission status at completion of course 1 and course 2.

  6. Reasons for failure to achieve CR (R1 & R2). [ Time Frame: 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. ]
    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.

  7. Cumulative Incidence of Relapse (CIR) (all randomisations). [ Time Frame: Evaluated as time from randomisation to the relevant question to relapse, up to 16 years. ]
    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.

  8. Death in CR (DCR) (R1, R2 & R3). [ Time Frame: 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. ]
    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.

  9. Event Free Survival (EFS) (R1, R2 & R3). [ Time Frame: 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. ]
    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.

  10. Overall Survival (OS) (all randomisations). [ Time Frame: 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. ]
    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.

  11. Incidence of toxicities (all randomisations). [ Time Frame: Evaluated 30 days after end of trial treatment. ]
  12. Incidence of cardiotoxicity (R1, R2 & R4 only). [ Time Frame: Evaluated 30 days after end of trial treatment. ]
  13. Incidence of bilirubin of grade 3 of higher (R2 & R4 only). [ Time Frame: Evaluated 30 days after end of trial treatment. ]
  14. Incidence of Veno-Occlusive Disease (R2 & R4 only). [ Time Frame: Evaluated 30 days after end of trial treatment. ]
  15. Minimal Residual Disease (MRD) clearance after course 1 & 2 (R1 & R2 only). [ Time Frame: Evaluated and presented at completion of course 1 and 2 of treatment, up to a maximum of 45 days post each course of treatment. ]
    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.

  16. Time to haematological recovery (all randomisations). [ Time Frame: Evaluated by day 45 post course 1 and course 2. ]
    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.

  17. Days in hospital after each course of treatment (all randomisations). [ Time Frame: Evaluated once all patients have completed trial treatment. ]
    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.

  18. Incidence of mixed chimerism at day 100 post-transplant (R4 only). [ Time Frame: Evaluated at day 100 post-transplant. ]
  19. Treatment Related Mortality (TRM) (R4 only). [ Time Frame: 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. ]
    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.

  20. Gonadal function (R4 only). [ Time Frame: 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. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion criteria for trial entry and R1 randomisation.

  • 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.
  • No prior chemotherapy or biological therapy for AML 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
  • Karnofsky or Lansky performance score of ≥50.
  • 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 participation in R2 (randomisation not yet open).

  • Patient meets the inclusion criteria for trial entry
  • Age ≥12 weeks.
  • Karnofsky or Lansky performance score of ≥50.
  • 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.
  • Pregnant or lactating females.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02724163


Contacts
Contact: Colin McAlister 01214151049 myechild01@trials.bham.ac.uk
Contact: Anna Lawson 01214151061 myechild01@trials.bham.ac.uk

Locations
United Kingdom
Royal Aberdeen Children's Hospital Recruiting
Aberdeen, United Kingdom, AB25 2ZG
Aberdeen Royal Infirmary, NHS Grampian Recruiting
Aberdeen, United Kingdom, AB25 2ZN
Belfast City Hospital, Belfast Health and Social Care Trust Not yet recruiting
Belfast, United Kingdom, BT9 7AB
Birmingham Children's Hospital NHS Foundation Trust Recruiting
Birmingham, United Kingdom, B4 6NH
University Hospitals Bristol NHS Foundation Trust Recruiting
Bristol, United Kingdom, BS1 3NU
Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, United Kingdom, CB2 0QQ
Cardiff and Vale University Health Board, Noah's Ark Children's Hospital for Wales Recruiting
Cardiff, United Kingdom, CF14 4XW
NHS Lothian, Royal Hospital for Sick Children Recruiting
Edinburgh, United Kingdom, EH9 1LF
NHS Greater Glasgow and Clyde, The Royal Hospital for Children Recruiting
Glasgow, United Kingdom, G51 4TF
Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust Recruiting
Leeds, United Kingdom, LS9 7TF
Alder Hey Children's NHS Foundation Trust Recruiting
Liverpool, United Kingdom, L12 2AP
University College London Hospitals NHS Foundation Trust Not yet recruiting
London, United Kingdom, NW1 2PG
The Royal Marsden NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6JJ
Great Ormond Street Hospital For Children NHS Trust Recruiting
London, United Kingdom, WC1N 3JH
Royal Manchester Childrens' Hospital , Central Manchester University Hospitals NHS Foundation Trust Recruiting
Manchester, United Kingdom, M13 9WL
The Christie NHS Foundation Not yet recruiting
Manchester, United Kingdom, M20 4BX
The Newcastle Upon Tyne Hospitals NHS Foundation Trust Recruiting
Newcastle, United Kingdom, NE7 7DN
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG7 2UH
John Radcliffe Hospital, Oxford Radcliffe Hospitals NHS Trust Recruiting
Oxford, United Kingdom, OX3 9DU
Sheffield Children's NHS Foundation Trust Recruiting
Sheffield, United Kingdom, S10 2TH
Southampton University Hospitals NHS Trust Not yet recruiting
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
University of Birmingham
Assistance Publique - Hôpitaux de Paris
Cancer Research UK
National Cancer Institute, France
Pfizer
Investigators
Principal Investigator: Brenda Gibson Royal Hospital for Children Glasgow

Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT02724163     History of Changes
Other Study ID Numbers: RG_14-088
2014-005066-30 ( EudraCT Number )
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Birmingham:
Acute Myeloid Leukaemia
Children
Gemtuzumab ozogamicin
Liposomal daunorubicin
Mitoxantrone
Randomised controlled trial
Risk stratification
Minimal residual disease
Stem cell transplant

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Leukemia
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cyclophosphamide
Fludarabine phosphate
Cytarabine
Busulfan
Fludarabine
Gemtuzumab
Mitoxantrone
Daunorubicin
Vidarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents