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AzTrials

Acute Myeloid LeukaemiaPhase 2/3AML18NCT02272478

Trial to Test the Effects of Adding 1 of 2 New Treatment Agents to Commonly Used Chemotherapy Combinations

A Phase 2/3 study testing Arm A Mylotarg plus DA Versus CPX-351, Arm B Vosaroxin and Decitabine and Arm D Small molecule or Not in people with Acute Myeloid Leukaemia and Myelodysplastic Syndrome, run by Cardiff University at 87 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The AML18 Trial will evaluate several relevant therapeutic questions in Acute Myeloid Leukaemia (AML), as defined by the WHO, and High Risk Myelodysplastic Syndrome. The trial is primarily designed for patients over 60 years considered fit for an intensive chemotherapeutic approach, but younger patients who may not be… Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Arm A Mylotarg plus DA Versus CPX-351, Arm B Vosaroxin and Decitabine and Arm D Small molecule or Not
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,600 participants
Where
87 sitesin 2 countries
Study dates
30 Oct 2014to Feb 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients are eligible for the AML18 trial if:
  • They have one of the forms of acute myeloid leukaemia, except Acute Promyelocytic Leukaemia as defined by the WHO Classification (Appendix A) this can be any type of de novo or secondary AML - or high risk Myelodysplastic Syndrome, defined as greater than 10% marrow blasts (RAEB-2). (NB patients with prior MDS (>10% blasts, RAEB2) have received azacitidine are not eligible for the trial, but patients with <10% who have failed a hypomethylating agent and developed AML may enter the trial).
  • Patients should normally be over the age of 60, but patients under this age are eligible if they are not considered eligible for the MRC AML19 trial please contact the trial team for further information.
  • Patients entering the Vosaroxin/Decitabine arm must be over the age of 60 and have known adverse risk cytogenetics.
  • They have given written informed consent.
  • Serum creatinine ≤ 1.5 × ULN (upper limit of normal)
  • Sexually mature males must agree to use an adequate and medically accepted method of contraception throughout the study if their sexual partners are women of child bearing potential (WOCBP). Men should be advised to not father a child while receiving trial treatment. Similarly women must agree to adequate contraceptive measures and avoid becoming pregnant while on protocol treatment. In both males and females these measures must be in place for at least 3 months following completion of Decitabine and at least 6 months after the last administration of Cladribine. The time period following treatment with Decitabine where it is safe to become pregnant is unknown. In the event of pregnancy at any point during the trial, the IMPs should be immediately stopped and the Trial Team should be contacted and pregnancy reporting procedures followed.
  • ECOG Performance Status of 0-2

Who cannot join

  • Patients are not eligible for the AML18 trial if:
  • They have previously received cytotoxic chemotherapy for AML [Hydroxycarbamide, or similar low-dose therapy, to control the white count prior to initiation of intensive therapy, is not an exclusion]
  • They are in blast transformation of chronic myeloid leukaemia (CML)
  • They have a concurrent active malignancy excluding basal cell carcinoma
  • They are pregnant or lactating
  • They have Acute Promyelocytic Leukaemia
Show all 29Show fewer
  • Known infection with human immunodeficiency virus (HIV)
  • Patients with prior cumulative anthracycline exposure (from prior treatment of a non AML cancer) of greater than 300 mg/m2 daunorubicin (or equivalent).
  • History of myocardial infarction (MI), unstable angina, cerebrovascular accident, or transient ischemic attack (CVA/TIA) within 3 months before entry
  • Specific exclusion criteria for the Mylotarg Arm
  • Pre-existing liver impairment with known cirrhosis
  • Total bilirubin > 1.5 x the upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) > 2.5 x ULN
  • Alanine aminotransferase (ALT) > 2.5 x ULN
  • Specific exclusion criteria for the Vosaroxin/Decitabine Entry
  • Total bilirubin > 1.5 x the upper limit of normal (ULN),
  • Aspartate aminotransferase (AST) > 2.5 x ULN
  • Alanine aminotransferase (ALT) > 2.5 x ULN
  • Left ventricular ejection fraction (LVEF) < 40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)]
  • Specific exclusion criteria for CPX-351 treatment
  • Hypersensitivity to cytarabine, daunorubicin or liposomal products
  • History of Wilson's disease or other copper-metabolism disorder
  • Specific exclusion criteria for Cladribine
  • Patient's serum creatinine must be within the local ULN to enter the randomisation. Patients for whom this is not the case can be randomised between the remaining options.
  • In addition patients are not eligible for the AC220 randomisation if they have:
  • Cardiovascular System Exclusion Criteria:
  • Known serious cardiac illness or medical conditions, including but not limited to:
  • Clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling temporary pacemaker II. Ventricular tachycardia or a supraventricular tachycardia that requires treatment with a Class Ia antiarrhythmic drug (e.g., quinidine, procainamide, disopyramide) or Class III antiarrhythmic drug (e.g., sotalol, amiodarone, dofetilide). Use of other antiarrhythmic drugs is permitted.
  • Use of medications that have been linked to the occurrence of torsades de pointes (see Appendix for the list of such medications) IV. Second- or third-degree atrioventricular (AV) block unless treated with a permanent pacemaker V. Complete left bundle branch block (LBBB) VI. History of long QT Syndrome or a family member with this condition VII. Serum potassium, magnesium, and calcium levels not outside the laboratory's reference range VIII. QTc >450 ms (average of triplicate ECG recordings); a consistent method of QTc calculation must be used for each patient's QTc measurements. QTcF (Fridericia's formula) is preferred. Please see the trial website for QTcF calculator.

Trial locations and contacts

87 sites in 2 countries.

Sophie King contact

02922510527

aml18@cardiff.ac.uk

87 sites in 2 countries

United Kingdom81 sites, 81 recruiting

  • Aberdeen Royal Infirmary

    Aberdeen

    Dominic Culligan, MD

    Recruiting

  • Monklands Hospital

    Airdrie

    John Murphy, MD

    Recruiting

  • Ysbyty Gwynedd Hospital

    Bangor

    Jim Seale, MD

    Recruiting

  • Royal United Hospital Bath

    Bath

    Chris Knechtli, MD

    Recruiting

  • Belfast City Hospital

    Belfast

    Mary McMullin, MD

    Recruiting

  • Birmingham Heartland Hospital

    Birmingham

    Manos Nikolousis, MD

    Recruiting

  • Queen Elizabeth Hospital

    Birmingham

    Charles Craddock, DPhil

    Recruiting

  • Blackpool Victoria Hospital

    Blackpool

    Paul Cahalin, MD

    Recruiting

  • Ysbyty Glan Clwyd

    Bodelwyddan

    Earnest Heartin, MD

    Recruiting

  • Pilgrim Hospital

    Boston

    Charlotte Kallmeyer, MD

    Recruiting

  • Royal Bournemouth General Hospital

    Bournemouth

    Joseph Chacko, MD

    Recruiting

  • Bradford Royal Infirmary

    Bradford

    Sam Ackroyd, MD

    Recruiting

  • Bristol Haematology & Oncology Centre

    Bristol

    Priyanka Mehta, MD

    Recruiting

  • Addenbrooke's Hospital

    Cambridge

    Kiran Tawana, MD

    Recruiting

  • UHW

    Cardiff, CF14 4XN

    Steve Knapper

    Recruiting

  • University Hospital of Wales

    Cardiff

    Steve Knapper, MD

    Recruiting

  • Cheltenham General Hospital

    Cheltenham

    Adam Rye, MD

    Recruiting

  • Countess of Chester Hospital

    Chester

    Arvind Pillai, MD

    Recruiting

  • St Richard's Hospital

    Chichester

    Santosh Narat, MD

    Recruiting

  • University Hospital of Coventry and Warwickshire

    Coventry

    Beth Harris, MD

    Recruiting

  • Derby Teaching Hospital

    Derby

    Ian Amott, MD

    Recruiting

  • Russell Hall

    Dudley

    Rupert Hipkins, MD

    Recruiting

  • Ninewells Hospital

    Dundee

    Sudhir Tauro, MD

    Recruiting

  • Western General Hospital

    Edinburgh

    Peter Johnson, MD

    Recruiting

  • Royal Devon & Exeter Hospital

    Exeter

    Jason Coppell, MD

    Recruiting

  • Beatson West of Scotland Cancer Centre

    Glasgow

    Mhairi Copland, MD

    Recruiting

  • Hairmyres Hospital

    Glasgow

    John Murphy, MD

    Recruiting

  • The New Victoria Hospital

    Glasgow

    Gail Loud, MD

    Recruiting

  • Gloucestershire Royal Hospital

    Gloucester

    Adam Rye, MD

    Recruiting

  • Royal Free Hospital

    Hamstead

    Panagiotis Kottaridis, MD

    Recruiting

  • Raigmore Hospital

    Inverness

    Caroline Duncan, MD

    Recruiting

  • Ipswich Hospital

    Ipswich

    Mahesh Prahladan, MD

    Recruiting

  • Crosshouse & Ayr Hospital

    Irvine

    William Gordon, MD

    Recruiting

  • Kettering General Hospital

    Kettering

    Mark Kwan, MD

    Recruiting

  • Victoria Hospital

    Kirkcaldy

    Victoria Campbell, MD

    Recruiting

  • Forth Valley Royal Hospital

    Larbert

    Hugh Edwards, MD

    Recruiting

  • St Jame's University Hospital

    Leeds

    Richard Kelly, MD

    Recruiting

  • Leicester Royal Infirmary

    Leicester

    Katherine Hodgson, MD

    Recruiting

  • Lincoln County Hospital

    Lincoln

    Charlotte Kallmeyer, MD

    Recruiting

  • Aintree University Hospital

    Liverpool

    Vikram Singh, MD

    Recruiting

  • The Royal Liverpool University Hospital

    Liverpool

    Amit Patel, MD

    Recruiting

  • Guy's Hospital

    London

    Kavita Raj, MD

    Recruiting

  • St Bartholomew's Hospital

    London

    Mathew Smith, MD

    Recruiting

  • St George's Hospital

    London

    Matthias Klammer, MD

    Recruiting

  • The Royal Marsden

    London

    David Taussig, M.D

    Recruiting

  • University College London Hospital

    London

    A Khwaja, MD

    Recruiting

  • Maidstone District General Hospital

    Maidstone

    Evangelia Dimitriadou, MD

    Recruiting

  • Manchester Royal Infirmary

    Manchester

    Eleni Tholouli, MD

    Recruiting

  • The Christie Hospital

    Manchester

    Mike Dennis, MD

    Recruiting

  • Arrowe Park Hospital

    Metropolitan Borough of Wirral

    Ranjit Dasgupta, MD

    Recruiting

  • The James Cook University Hospital

    Middlesbrough

    Ray Dang, MD

    Recruiting

  • Milton Keynes

    Milton Keynes

    Moez Dungarwalla, MD

    Recruiting

  • Freeman Hospital

    Newcastle

    Gail Jones, MD

    Recruiting

  • Northampton General Hospital

    Northampton

    Jane Parker, MD

    Recruiting

  • Norfolk & Norwich University

    Norwich

    Angela Collins, MD

    Recruiting

  • Nottingham University Hospital

    Nottingham

    Nigel Russell, MD

    Recruiting

  • Royal Oldham Hospital

    Oldham

    David Osborne, MD

    Recruiting

  • Churchill Hospital

    Oxford

    Paresh Vyas, MD

    Recruiting

  • Derriford Hospital

    Plymouth

    Patrick Medd, MD

    Recruiting

  • Queen Alexandra Hospital

    Portsmouth

    Robert Corser, MD

    Recruiting

  • Whiston Hospital & St Helens

    Prescot

    Toby Nicholson, MD

    Recruiting

  • Queen's Hospital

    Romford

    Paul Greaves, MD

    Recruiting

  • Salford Royal Hospital

    Salford

    Rowena Thomas-Dewing, MD

    Recruiting

  • Salisbury District Hospital

    Salisbury

    Jonathan Cullis, MD

    Recruiting

  • Wexham Park Hospital

    Slough

    Mark Offer, MD

    Recruiting

  • Southampton General Hospital

    Southampton

    Deborah Richardon, MD

    Recruiting

  • Stafford Hospital

    Stafford

    Paul Revell, MD

    Recruiting

  • University Hospital of Royal Stoke

    Stoke-on-Trent

    Srivinas Pillai, MD

    Recruiting

  • Sunderland Royal Hospital

    Sunderland

    Shikha Chattree, MD

    Recruiting

  • St Helier Hospital

    Sutton

    Simon Stern, MD

    Recruiting

  • Singleton Hospital

    Swansea

    Unmesh Monite, MD

    Recruiting

  • Torbay District General Hospital

    Torquay

    Deborah Turner, MD

    Recruiting

  • Royal Cornwall Hospital

    Truro

    Bryson Pottinger, MD

    Recruiting

  • Hillingdon Hospital

    Uxbridge

    Richard Kaczmarski, MD

    Recruiting

  • Pinderfields Hospital

    Wakefield

    Paul Moreton, MD

    Recruiting

  • Sandwell Hospital

    West Bromwich

    Farooq Wandroo, MD

    Recruiting

  • Wishaw General Hospital

    Wishaw

    John Murphy, MD

    Recruiting

  • New Cross Hospital

    Wolverhampton

    Richard Whitmill, MD

    Recruiting

  • Worcestershire Royal Hospital

    Worcester

    Nicholas Pemberton, MD

    Recruiting

  • Worthing Hospital

    Worthing

    Santosh Narat, MD

    Recruiting

  • York Hospital

    York

    Lee Bond, MD

    Recruiting

Other trials in United Kingdom

Denmark6 sites, 6 recruiting

  • Aalborg University Hospital

    Aalborg

    Marianne Severinsen, MD

    Recruiting

  • Aarhus University Hospital

    Aarhus

    Hans B Ommen, MD

    Recruiting

  • Herlev and Gentofte Hospital

    Copenhagen

    Claudia Schöllkopf, MD

    Recruiting

  • Rigshospitalet

    Copenhagen

    Ulrik M Overgaard, MD

    Recruiting

  • Odense University Hospital

    Odense

    Duruta Weber, MD

    Recruiting

  • Roskilde Hospital

    Roskilde

    Peter Møller

    Recruiting

Other trials in Denmark

About this study

Official title: A Trial for Older Patients With Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome

The AML18 Trial will evaluate several relevant therapeutic questions in Acute Myeloid Leukaemia (AML), as defined by the WHO, and High Risk Myelodysplastic Syndrome. The trial is primarily designed for patients over 60 years considered fit for an intensive chemotherapeutic approach, but younger patients who may not be considered suitable for the concurrent NCRI AML Trial for younger patients may also enter. Patients for whom intensive chemotherapy is not thought suitable may enter the concurrent NCRI trial of less intensive therapy (LI1). Approximately 1600 patients will be recruited.

At entry, a randomisation will compare a standard chemotherapy schedule DA (Daunorubicin/Ara-C) combined with 1 dose of Mylotarg (gemtuzumab ozogamicin, or GO) in course 1 against CPX-351. Patients who have known adverse risk cytogenetics (using Grimwade 2010 classification favourable/intermediate/adverse) at diagnosis may enter a Phase 2 evaluation of the combination of Vosaroxin plus Decitabine. Patients who achieve complete remission (CR) and who are MRD negative by flow cytometry after course one of DA will receive one further course of DA, with a randomisation to receive, either a course of DA or intermediate dose Cytarabine (IDAC) as a third course. Patients who are MRD negative by flow cytometry after course one of CPX-351 will receive up to 2 further course of CPX. Patients who fail to achieve a CR after course 1 of DA or who are MRD positive by flow cytometry or for whom MRD information is not available, are eligible to be randomised to compare DA with DA plus Cladribine (DAC) or FLAG-Ida for up to two courses of therapy. Patients who fail to achieve a CR after course 1 of CPX-351 or who are MRD positive by flow cytometry or for whom MRD information is not available are eligible to be randomised between a second course of standard dose CPX versus a repeat of the course 1 schedule. Patients receiving Vosaroxin and Decitabine are excluded from these post course 1 randomisations .

Read more

Following the outcome of course 1, patients who received DA chemotherapy on course 1 will be randomised to receive further chemotherapy with the 2nd generation FLT3 inhibitor AC220. Patients randomised to AC220 will be allocated a maximum of 3 courses (short AC220) or 3 courses plus maintenance for 1 year (long AC220). Patients receiving Vosaroxin and Decitabine are excluded from this randomisation.

Patients will be eligible for a non-intensive allogeneic stem cell transplant if a suitable HLA matched donor is available.

Read the detailed description

AML18 is a trial primarily for older patients with AML and high risk Myelodysplastic Syndrome (MDS). It offers a randomised controlled Phase II/III trial which uses a factorial design for maximum efficiency to evaluate two induction options followed by treatment with small molecule beyond course 1, and dose intensification for patients without evidence of MRD negativity.

There are five randomised comparisons within the trial:

  1. At diagnosis: For patients not known to have adverse risk cytogenetics DA chemotherapy plus a single dose of 3 mg/m2 of Mylotarg versus CPX-351. Patients with abnormal LFTs can enter the randomisation but receive DA alone or CPX-351.
  2. For patients who received DA chemotherapy but are not in CR or who are MRD +ve, or for whom MRD is not assessable. DA versus DAC versus FLAG-Ida
  3. All patients at second course who have received DA and have not received Vosaroxin and Decitabine induction AC220 versus no AC220 for a maximum of 3 cycles; then with or without maintenance for 1 year for patients allocated AC220
  4. For patients who are in CR or CRi and MRD -ve post course1 and have completed 2 courses of DA DA versus intermediate dose Cytarabine (IDAC)
  5. For patients who received CPX-351 chemotherapy but are not in CR or who are MRD +ve, or for whom MRD is not assessable CPX-351 100 units/m2 x 3 doses versus CPX-351 100 units/m2 x 2 doses

The trial will also assess:

  • Non-intensive allogeneic stem cell transplant for patients with matched sibling or matched unrelated donors.
  • The combination of Vosaroxin and Decitabine for those with known adverse risk cytogenetics at diagnosis
Being tested
Arm A Mylotarg plus DA Versus CPX-351, Arm B Vosaroxin and Decitabine, Arm D Small molecule or Not, Arm C DA V FLAG-Ida V DAC, Arm E CPX-351 (200 V 300)
Keywords
AML, MDS
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arm A Mylotarg plus DA Versus CPX-351Drug

    Also called Mylotarg (GO), CPX-351

    Patients not known to have adverse risk cytogenetics will enter a randomisation comparing DA with Mylotarg (GO) delivered at 3mg/m2 on day 1 of chemotherapy, with CPX-351 on days 1, 3 and 5.

  • Arm B Vosaroxin and DecitabineDrug

    Also called Vosaroxin, Decitabine

    If a patient is known to have adverse risk Cytogenetics at diagnosis they will enter a registration to receive up to 5 courses of Vosaroxin and Decitabine.

  • Arm D Small molecule or NotDrug

    Also called No AC220

    The randomisation to AC220 or not will take place immediately before course 2 of treatment for patients who have received DA induction +/- Mylotarg, irrespective of residual disease status. Patients allocated to receive AC220 will be randomised in a 1:1 fashion to AC220 or no small molecule with a 1:1 randomisation in patients drawing AC220 between short and long therapy.

  • Arm C DA V FLAG-Ida V DACDrug

    Also called DA, FLAG-Ida, DAC

    If a patient is not in CR or CRi after course 1 or is MRD +ve/unknown by flow cytometry they will be eligible to be randomised in a 1:1:1 fashion between DA, FLAG-Ida (or mini FLAG-Ida if 70 years or older) and DAC.

  • Arm E CPX-351 (200 V 300)Drug

    Also called CPX-351

    If a patient is not in CR or CRi after course 1 or is MRD +ve/unknown by flow cytometry they will be eligible to be randomised in a 1:1 fashion between CPX given on days 1, 3 and 5 (3 doses) and CPX given on days 1 and 3 (2 doses).

  • Arm F DA V IDACDrug

    Also called IDAC, DA

    Following recovery from course 2, patients in the MRD-ve arm will be randomised between a further 5-day cycle of DA or a cycle of intermediate dose cytarabine (IDAC) as the third chemotherapy course.

Study groups in NCT02272478
Study groupRoleWhat they receive
Arm AActive comparatorPatients not known adverse karyotype Randomise between Daunorubicin 60mg/m2 daily by i.v. infusion on days 1, 3 and 5 (3 doses) Cytosine Arabinoside 100mg/m2 12 hourly by i.v. push on days 1 - 10 inclusive (20 doses) Mylotarg (GO) 3mg/m2 on day 1 of DA chemotherapy Versus CPX-351 100 units/m2 on days 1, 3 and 5
Receives: Drug: Arm A Mylotarg plus DA Versus CPX-351
Arm BActive comparatorPatients with known adverse karyotype 5 cycles of Vosaroxin and Decitabine therapy
Receives: Drug: Arm B Vosaroxin and Decitabine
Arm CActive comparatorPrior to Course 2 - Patients receving DA plus GO in course 1 and MRD positive PC1 Randomise between Daunorubicin 50mg/2 daily by i.v. infusion on days 1, 3 and 5 (3 doses) Cytosine Arabinoside 100mg/m2 12 hourly by i.v.push on days 1 - 8 inclusive (16 doses) Versus Daunorubicin 50mg/m2 daily by i.v. infusion on days 1, 3 and 5 Cytosine Arabinoside 100mg/m2 12 hourly by i.v. push on days 1 - 8 inclusive Cladribine 5mg/m2 daily on days 1 - 5 inclusive Versus Patients aged 60-69 Fludarabine 30mg/m2 daily on i.v. on days 2 - 6 inclusive Cytosine Arabinoside 1g/m2 daily over 4 hours Fludarabine on days 2 - 6 inclusive Patients aged 70+ Fludarabine 25mg/m2 daily i.v. on days 2 - 5 inclusive Cytosine Arabinoside 1g/m2 daily over 4 hours Fludarabine on days 2 - 5 inclusive Idarubicin 5mg/m2 i.v. daily on days 3, 4 and 5 (3 doses) And Randomisation to receive AC220 or not
Receives: Drug: Arm D Small molecule or Not; Drug: Arm C DA V FLAG-Ida V DAC
Arm DActive comparatorPrior to Course 2 - Patients that received DA plus GO in course 1 and MRD negative PC1 Randomisation to receive AC220 or not
Receives: Drug: Arm D Small molecule or Not
Arm EActive comparatorPrior to Course 2 for patients receiving CPX in course 1 and MRD positive PC1 Randomisation between CPX-351 100 units/m2 on days 1, and 3 (CPX 200) versus CPX-351 100 units/m2 on days 1, 3 and 5 (CPX 300)
Receives: Drug: Arm E CPX-351 (200 V 300)
Arm FActive comparatorPrior to Course 3 - Patients that received DA plus GO in course 1 and MRD negative PC1 Randomise between Daunorubicin 50 mg/m2 daily by i.v. infusion on days 1 and 3 (2 doses) Cytosine Arabinoside 100 mg/m2 12-hourly by i.v. push on days 1 - 5 inclusive (10 doses) versus Intermediate dose Cytarabine (IDAC) schedule Cytosine Arabinoside 1g/m2 daily by 4 hour infusion on days 1- 5 inclusive (5 doses)
Receives: Drug: Arm F DA V IDAC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: 1 year

  2. Complete remission (CR + CRi) achievement and reasons for failure (for induction questions)

    Measured: 1 month

  3. Duration of remission, relapse rates and deaths in first CR

    Measured: 1 month

  4. Toxicity, both haematological and non-haematological

    Measured: 1 month

  5. Supportive care requirements (and other aspects of health economics)

    Measured: 6 months

Secondary outcomes (3)

  1. The relevance of the presence of a cytogenetic abnormality in the bone marrow of patients in morphological remission

    Measured: At study end

  2. The relevance of molecular characteristics and response to treatment

    Measured: 1 month

  3. To store diagnostic tissue for future research in the AML Tissue Bank

    Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2014 (estimated)
  2. Study start30 Oct 2014
  3. Primary completionFeb 2021 (estimated)
  4. Study completionFeb 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
1,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02272478
Sponsor's protocol ID
AML18
Acronym
AML18
Status last verified
Aug 2019
First submitted
10 Jun 2014
Last updated
23 Jan 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Knapper S, Dillon LW, Babu M, Thomas A, Thomas I, Hourigan CS, Andrew G, Dillon R, Gilkes A, Marquez Almuina N, King S, McCarthy N, Bahr R, Al-Ali RW, Stone L, Coats T, Byrne J, Green S, Overgaard UM, Sellar RS, Dennis M, Mehta P, Hills R, Freeman SD, Russell NH. CPX-351 vs daunorubicin, cytarabine, and gemtuzumab ozogamicin in older adults with non-adverse-risk AML: the NCRI AML18 trial. Blood. 2026 Mar 5;147(10):1048-1057. doi: 10.1182/blood.2025031006.

    PubMed 41237344

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Arm A Mylotarg plus DA Versus CPX-351, Arm B Vosaroxin and Decitabine and Arm D Small molecule or Not in people with Acute Myeloid Leukaemia and Myelodysplastic Syndrome, run by Cardiff University at 87 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United Kingdom, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sophie King (02922510527, aml18@cardiff.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02272478, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.

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