Contact information
Type
Scientific
Primary contact
Dr DW Milligan
ORCID ID
Contact details
Department of Haematology
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
+44 (0)121 424 3699
d.w.milligan@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00005863
Protocol/serial number
G9800529
Study information
Scientific title
Acute Myeloid Leukaemia - High Risk (AML-HR)
Acronym
AML-HR
Study hypothesis
To improve the outcome of patients with high risk AML by randomised evaluation of:
1. The standard ADE (Ara-C,daunorubicin, etoposide) reinduction regimen versus the newer FLA (fludarabine, high-dose Ara-C) regimen
2. The addition of growth factor (G-CSF) during and after chemotherapy.
3. The addition of retinoic acid (ATRA) during and after chemotherapy. Patients may be entered into all three randomisations, any combination of two randomisations, or just one randomisation. The therapeutic relevance of morphology, genetics and other features will also be investigated.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
Leukaemia
Intervention
Three randomised comparisons:
1. ADE versus FLA
2. Granulocyte Colony Stimulating Factor (G-CSF) versus control
3. All-trans-retinoic acid (ATRA) versus control
Follow-up until death.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Survival
2. Complete remission (CR) rates and reason for failure
3. Duration of remission
4. Toxicity
5. Quality of life
5. Supportive care requirements
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/1998
Overall trial end date
31/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. High risk acute myeloid leukaemia (AML) (de novo or secondary, except acute promyelocytic leukemia [APL])
2. Suitable for intensive therapy
3. Informed consent given. High risk AML is defined as:
(a) Resistant disease (greater than 15% blasts in bone marrow) after one induction course
(b) Refractory disease (ie not in complete remission [CR]) after two or more induction courses
(c) Relapse from first CR (with more than 5% blasts in bone marrow)
(d) In complete or partial remission after one induction course but with adverse cytogenic abnormalities at diagnosis
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
600
Participant exclusion criteria
1. APL
2. Concurrent active malignancy
3. Blast transformation of CML
4. Relapse from second or greater CR
5. Severe renal impairment (creatinine clearance less than 30 millilitres per minute)
6. Pregnant, lactating or potentially fertile and not taking adequate contraceptive precautions
Recruitment start date
01/11/1998
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Haematology
Birmingham
B9 5SS
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Publication citations
-
Results
Milligan DW, Wheatley K, Littlewood T, Craig JI, Burnett AK, , Fludarabine and cytosine are less effective than standard ADE chemotherapy in high-risk acute myeloid leukemia, and addition of G-CSF and ATRA are not beneficial: results of the MRC AML-HR randomized trial., Blood, 2006, 107, 12, 4614-4622, doi: 10.1182/blood-2005-10-4202.