| Source of record | UK Trials |
| ISRCTN | ISRCTN62207270 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | LRF AML14 |
| Public title | A randomised trial for patients with acute myeloid leukaemia (AML) or high-risk myelodysplastic syndrome aged 60 or over |
| Scientific title |
|
| Acronym | AML 14 |
| Disease/condition/study domain | Acute myeloid leukaemia or high-risk myelodysplastic syndrome |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patients are eligible for AML 14 if:
1. They have one of the forms of acute myeloid leukaemia (this can be any type of the de novo or secondary AML, except acute promyelocytic leukaemia) or myelodysplastic syndrome (refractory anemia with excess blasts [RAEB], refractory anemia with excess blasts in transformation [RAEB-t], chronic myelomonocytic leukemia [CMML]) with more than 10% myeloblasts in the bone marrow
2. They should normally be aged 60 or over, but patients under this age are eligible if the more intensive therapy employed in the current trial for younger patients with AML is not considered a suitable option
3. They have given informed consent |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/12/1998 |
| Anticipated end date | 01/11/2003 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Patients will be randomised between intensive and non-intensive chemotherapy at diagnosis.
Those in the intensive treatment arm will be randomised between 50 mg/m^2/day Daunorubicin versus 35 mg/m^2/day Daunorubicin and 200 mg/m^2/day Ara-C versus 400 mg/m^2/day.
Patients in the lower dose Daunorubicin arm will be further randomised between PSC833 versus control, ie no PSC833.
After three courses of treatment, patients in the intensive arm will be randomised between short (three courses) versus long (four courses) consolidation therapy.
Patients in the non-intensive arm will be randomised between hydroxyurea and low-dose Ara-C and 45 mg/m^2/day All-trans retinoic acid versus no retinoic acid. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Publications | Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&dopt=AbstractPlus&list_uids=17315155 |
| Sources of funding | Leukaemia Research Fund (UK) |
| Sponsor name | Leukaemia Research Fund (UK) |
| Sponsor details | 43 Great Ormond Street
London
United Kingdom
WC1N 3JJ |
| Sponsor website | http://dspace.dial.pipex.com/lrf-// |
| Contact name | Prof AK Burnett |
| Contact details | Department of Haematology
University of Wales College of Medicine
Heath Park
Cardiff
United Kingdom
CF14 4XN |
| Contact telephone | +44 (0)29 2074 2375 |
| Contact fax | +44 (0)29 2074 4655 |
| Contact email | burnettak@cardiff.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN62207270 |
| Date last extracted from ISRCTN register | 17/04/2008 |
