AML16; A National Cancer Research Institute Trial in Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndromes - AML 16
- Conditions
- Acute Myeloid Leukaemia and High Risk Myelodysplastic SyndromeMedDRA version: 7.1 Level: LLT Classification code 10000880
- Registration Number
- EUCTR2005-002847-14-GB
- Lead Sponsor
- Cardiff University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 2000
Inclusion Criteria
Patients are eligible for the AML16 trial if:
They have one of the forms of acute myeloid leukaemia as defined by the 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)
—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.
—They have given written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria
Patients are not eligible for the AML15 trial if:
—They 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.]
—They are in blast transformation of chronic myeloid leukaemia (CML).
They have a concurrent active malignancy.
—They are pregnant or lactating.
—Patients with abnormal liver function tests exceeding twice the local upper limit of normal are not eligible for the Mylotarg randomisations.
—Patients with Acute Promyelocytic Leukaemia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method