| Source of record | Leukaemia Research Fund |
| ISRCTN | ISRCTN62207270 |
| Serial number at source | 62207270 |
| Other organisations' reference numbers | N0263048543, N0083036248, N0411041624, N0411035333, N0013035970, N0025048928, N0217052719 (NRR) |
| Title of trial/grant title | A randomised trial for patients with acute myeloid leukaemia or high-risk myelodysplastic syndrome aged 60 or over |
| Acronym | AML 14 |
| Disease or condition | Acute Myeloid Leukaemia (AML) or High-Risk Myelodysplastic Syndrome |
| Current status of trial | Open |
| Patient information material | Patient Information Sheets can be obtained from the Birmingham Clinical Trials Unit |
| Topic/hypothesis/clinical objectives | The aim of this trial is to compare two strategies of treatment for patients with Acute Myeloid Leukaemia or High-Risk Myelodysplastic Syndrome and to compare treatment options within these two strategies. The main objective is to determine whether there are differences in response rates, survival, quality of life and supportive care requirements between the two strategies in patients where there is uncertainty as to the best treatment approach. |
| Design/methodology | Randomised controlled trial |
| Eligibility criteria - inclusion | 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 over 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 |
| Eligibility criteria - exclusion | Patients are not eligible for AML 14 if:
1. They have previously received cytotoxic chemotherapy for leukaemia
2. They have Acute Promyelocytic Leukaemia
3. They are in blast transformation of Chronic Myeloid Leukaemia
4. They have a concurrent active malignancy |
| Randomised 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/m2/day Daunorubicin versus 35 mg/m2/day Daunorubicin and 200 mg/m2/day Ara-C versus 400 mg/m2/day.
Patients in the lower dose Daunorubicin arm will be further randomised between PSC833 versus control, i.e. no PSC833.
After 3 courses of treatment, patients in the intensive arm will be randomised between short (3 courses) versus long (4 courses) consolidation therapy.
Patients in the non-intensive arm will be randomised between Hydroxyurea and low-dose Ara-C and 45 mg/m2/day All-trans retinoic acid versus no retinoic acid. |
| Sources of funding | Leukaemia Research Fund |
| Contact name(s) | Professor A K Burnett |
| Contact details | Department of Haematology
University of Wales College of Medicine
Heath Park
Cardiff
CF4 4XN
UK
Tel: +44 (0)29 2074 2375
Fax: +44 (0)29 2074 4655
Email: burnettak@cardiff.ac.uk |
| Further information | This trial register was updated in October 2003. Further information can be obtained from the lead researcher named above, or from the National Cancer Research Network database. |
| Date live in mRCT | 03 August 2004 |
