Acute Myloid Leukaemia (AML) and High Risk Myelodysplastic Syndrome (MDS). Cancer Leukaemia
Conditions
Interventions
Current interventions as of 04/08/2011:
Intensive interventions:
There are three randomised comparisons within the trial:
At diagnosis:
Sponsors
Cardiff University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. They have one of the forms of acute myeloid leukaemia, except acute promyelocytic leukaemia, as defined by the World Health Organisation (WHO) Classification - 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) 2. They should normally be over the age of 60, but patients under this age are eligible if they are not considered fit for the MRC AML 15 trial 3. They have given written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients have previously received cytotoxic chemotherapy for AML. (Hydroxyurea, or similar low-dose therapy, to control the white count prior to initiation of intensive therapy is not an exclusion.) 2. They are in blast transformation of chronic myeloid leukaemia (CML) 3. They have a concurrent active malignancy 4. They are pregnant or lactating 5. Patients with abnormal liver function tests exceeding twice the local upper limit of normal are not eligible for the Mylotarg randomisations 6. Patients with Acute Promyelocytic Leukaemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For intensive treatment: Overall survival, complete remission (CR) achievement and reasons for failure (for induction questions), duration of remission, relapse rates and deaths in 1st CR. For non?intensive treatments: Overall survival, including survival at 6 months for the initial assessment of whether to continue with a novel therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| For intensive treatment: Toxicity as assessed by NCI/WHO definitions; days to haematological recovery; supportive care requirements (days on antibiotics, days in hospital, blood product support). For non-intensive treatment: Toxicity as assessed by NCI/WHO definitions; days to haematological recovery; supportive care requirements (days on antibiotics, days in hospital, blood product support); complete remission (CR) achievement and reasons for failure, duration of remission, relapse rates and deaths in 1st CR. | — |
Countries
United Kingdom, Wales
Outcome results
None listed