Acute Myeloid Leukaemia - High Risk (AML-HR)

ISRCTN	ISRCTN88373119
DOI	https://doi.org/10.1186/ISRCTN88373119
ClinicalTrials.gov (NCT)	NCT00005863
Protocol serial number	G9800529
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr DW Milligan
Scientific

Department of Haematology
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom

Phone	+44 (0)121 424 3699
Email	d.w.milligan@bham.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Acute Myeloid Leukaemia - High Risk (AML-HR)
Study acronym	AML-HR
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	600
Key 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
Key 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
Date of first enrolment	01/11/1998
Date of final enrolment	31/12/2004

Department of Haematology

Birmingham
B9 5SS
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	15/06/2006		Yes	No
Plain English results				No	Yes

17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)