AML17: a programme of treatment development in younger patients with Acute Myeloid Leukaemia and high-risk myelodysplastic syndrome
| ISRCTN | ISRCTN55675535 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55675535 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | 2007-003798-16 |
| Protocol serial number | CU 372-07 |
| Sponsor | Cardiff University (UK) |
| Funders | Cancer Research UK (CRUK) (UK), Genzyme Ltd (UK) - supplying clofarabine, Novartis Pharmaceuticals UK Limited (UK) - supplying mTOR inhibitor, Cephalon UK Ltd (UK) - providing arsenic trioxide and CEP-701, Bioenvision Ltd (UK) - providing clofarabine |
- Submission date
- 21/06/2007
- Registration date
- 02/07/2007
- Last edited
- 01/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
http://www.cancerhelp.org.uk/trials/a-trial-looking-treatment-children-acute-myeloid-leukaemia-aml-17
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-acute-myeloid-leukaemia-aml-17
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-treatment-acute-promyelocytic-leukaemia-AML-17
Contact information
Scientific
School of Medicine
Cardiff University
Heath Park
Cardiff
CF14 4XN
United Kingdom
| Phone | +44 (0)29 2074 2375 |
|---|---|
| BurnettAK@Cardiff.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | AML17: a programme of treatment development in younger patients with Acute Myeloid Leukaemia and high-risk myelodysplastic syndrome |
| Study acronym | AML17 |
| Study objectives | Best chemotherapy +/- molecular intervention and risk-directed chemotherapy. |
| Ethics approval(s) | MREC for Wales, 08/10/2008, ref: 08/MRE09/29 |
| Health condition(s) or problem(s) studied | Acute myeloid leukaemia/high-risk myelodysplastic syndrome |
| Intervention | Current interventions as of 24/06/2008: 1. In acute promyelocytic leukaemia (APL) patients to compare idarubicin and all-trans retinoic acid (ATRA) versus ATRA and arsenic 2. In non-APL patients to compare ara-C/dauno/etoposide (ADE) alone versus ADE or ara-C/dauno (DA) each with Mylotarg at two different doses (five arms): 2.1. ADE alone 2.2. ADE and Mylotarg (3 mg) 2.3. DA and Mylotarg (3 mg) 2.4. ADE and Mylotarg (6 mg) 2.5. DA and Mylotarg (6 mg) 3. Three versus four courses of total therapy 4. +/- CEP-701 (lestaurtinib) in FLT3 mutants 5. Dauno and clofarabine versus fludarabine, cytarabine, granulocyte colony-stimulating factor, and idarubicin (FLAG-Ida) in high-risk patients 6. +/- mTOR inhibition in non-CBF, non-FLT3 mutant, in non-high risk patients The treatment period is approximately 4 to 6 months. Previous interventions: 1. In acute promyelocytic leukaemia (APL) patients to compare idarubicin and all-trans retinoic acid (ATRA) versus ATRA and arsenic 2. In non-APL patients to compare ara-C/dauno/etoposide (ADE) alone versus ADE or ara-C/dauno (DA) each with Mylotarg at two different doses (five arms): 2.1. ADE alone 2.2. ADE and Mylotarg (3 mg) 2.3. DA and Mylotarg (3 mg) 2.4. ADE and Mylotarg (6 mg) 2.5. DA and Mylotarg (6 mg) 3. Three versus four courses of total therapy 4. +/- CEP-701 (lestaurtinib) in FLT3 mutants 5. Dauno and clofarabine versus dauno and cloretazine versus fludarabine, cytarabine, granulocyte colony-stimulating factor, and idarubicin (FLAG-Ida) in high-risk patients 6. +/- mTOR inhibition in non-CBF, non-FLT3 mutant, in non-high risk patients The treatment period is approximately 4 to 6 months. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Idarubicin, all-trans retinoic acid (ATRA), arsenic, ara-C/dauno/etoposide (ADE), ara-C/dauno (DA), mylotarg (gemtuzumab ozogamicin), lestaurtinib, clofarabine, cloretazine, fludarabine, cytarabine, granulocyte colony-stimulating factor |
| Primary outcome measure(s) |
1. Complete remission (CR), measured at approximately 1 month and if required approximately 6 weeks later i.e. after course 1 and/or 2 |
| Key secondary outcome measure(s) |
1. Detection of minimal residual disease |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 2700 |
| Key inclusion criteria | 1. They have one of the forms of acute myeloid leukaemia (AML) as defined by the World Health Organization (WHO) 2. They are considered suitable for intensive chemotherapy 3. They are less than 60 years 4. For Mylotarg (gemtuzumab ozogamicin) intervention, have liver function tests within twice the upper limit of normal |
| Key exclusion criteria | 1. No previous cytotoxic therapy for AML other than hydroxyurea 2. Blast transformation of chronic myeloid leukaemia (CML) 3. Concurrent active malignancy 4. Pregnant or lactating 5. Children with Down's syndrome |
| Date of first enrolment | 01/09/2008 |
| Date of final enrolment | 01/07/2014 |
Locations
Countries of recruitment
- United Kingdom
- Wales
- Denmark
Study participating centre
CF14 4XN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/06/2015 | Yes | No | |
| Results article | results | 01/10/2015 | Yes | No | |
| Results article | results | 04/02/2016 | Yes | No | |
| Results article | results | 01/06/2016 | Yes | No | |
| Results article | results | 02/03/2017 | Yes | No | |
| Results article | results | 27/02/2020 | 15/01/2020 | Yes | No |
| Results article | 10/03/2021 | 28/09/2021 | Yes | No | |
| Results article | 01/05/2025 | 01/05/2025 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 25/10/2022 | No | Yes | ||
| Plain English results | 25/10/2022 | No | Yes |
Editorial Notes
01/05/2025: Publication reference added.
25/10/2022: Cancer Research UK plain English results links added.
28/09/2021: Publication reference added.
03/04/2020: The following changes were made to the trial record:
1. The EudraCT number was added.
2. Locations: Southern Ireland was initially intended to open as a recruiting centre, but the site was unable to open for AML17.
02/04/2020: The following changes were made to the trial record:
1. The overall end date was changed from 01/07/2014 to 31/12/2020.
2. The target number of participants was changed from 2800 to 2700.
15/01/2020: Publication reference added.
13/12/2016: Publication reference added.
29/02/2016: Publication reference added.
15/02/2016: Publication reference added.
22/02/2011: The following changes were made to the trial record:
1. The overall trial end date was changed from 01/10/2013 to 01/07/2014.
2. The target participant number was changed from 2500 to 2800.
24/06/2008: The following changes were made to the trial record:
1. The overall trial start date was changed from 01/10/2007 to 01/09/2008.
2. The overall trial end date was changed from 01/08/2012 to 01/10/2013.
3. The sources of funding field was updated. Previous sources of funding:
1. Medical Research Council (MRC) (UK) (decision pending)
2. Cephalon UK Ltd (UK) (providing arsenic trioxide and CEP-701)
3. Wyeth (UK) (providing Mylotarg® and temsirolimus)
4. Vion (UK) (providing cloretazine)
5. Bioenvision Ltd (UK) (providing clofarabine)
