Acute myeloid leukaemia (AML) trial 12 (protocol for children)

ISRCTN	ISRCTN64649191
DOI	https://doi.org/10.1186/ISRCTN64649191
ClinicalTrials.gov (NCT)	NCT00003436
Protocol serial number	G8223452
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (UK)

Submission date: 25/10/2000
Registration date: 25/10/2000
Last edited: 14/01/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr BEG Gibson
Scientific

Department of Haematology
Royal Hospital for Sick Children
Yorkhill
Glasgow
G3 8SJ
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	AML 12
Study objectives	To compare two induction schedules (ADE and MAE) with respect to achievement and duration of remission, survival, toxicity and supportive care requirements; to compare four versus five course of treatment in total (where the final course is either chemotherapy or BMT) with respect to remission duration, relapse rates, deaths in remission and overall survival, to compare the value of allogeneic BMT vs. conventional chemotherapy with respect to remission duration, relapse rates, death in remission and overall survival, to reduce toxicity without compromising survival by restricting the number of patients receiving BMT. To evaluate the therapeutic relevance of morphological, cytogenetic, molecular-genetic and immunophenotype assessments, quality of life assessment and economic evaluation and monitoring cardiac function with observation at trial entry, prior to each antracycline/anthracenedione-containing course, prior to allograft and within 4 weeks of the end of therapy.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Leukaemia
Intervention	ADE/MAE
Intervention type	Other
Primary outcome measure(s)	Achievement and duration of remission, survival, febrile incidents, toxicity including cardiotoxicity, supportive care requirements and long-term outcome.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2002

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	16 Years
Sex	All
Target sample size at registration	2000
Key inclusion criteria	1. They have one of the types of acute myeloid leukaemia (de novo or secondary) 2. They have aggressive myelodysplastic syndrome (MDS) (Refractory anemia with excess blasts [RAEB], Refractory anemia with excess blasts in transformation [RAEB-t]) for whom AML-type therapy is considered appropriate 3. They are considered suitable for intensive chemotherapy 4. They are under 16 years and if the patients/parents have given informed consent
Key exclusion criteria	1. Patients who have previously received cytotoxic chemotherapy for leukaemia; 2. They are in blast transformation of chronic myeloid leukaemia; 3. They have a concurrent active malignancy or the physician and patient/parents consider that intensive therapy is not an appropriate option.
Date of first enrolment	01/04/1995
Date of final enrolment	01/01/2002

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Department of Haematology

Glasgow
G3 8SJ
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2005		Yes	No