AML 12 - Acute myeloid leukaemia Adults (modified)

ISRCTN	ISRCTN17833622
DOI	https://doi.org/10.1186/ISRCTN17833622
Protocol serial number	G8223452
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

Submission date: 25/10/2000
Registration date: 25/10/2000
Last edited: 25/07/2019

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

Prof AK Burnett
Scientific

Department of Haematology
University of Wales College of Medicine
Heath Park
Cardiff
CF14 4XN
United Kingdom

Phone	+44 (0)29 2074 2375
Email	burnettak@cardiff.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	AML 12 - Acute myeloid leukaemia Adults (modified)
Study acronym	AML 12
Study objectives	To improve the outcome of patients with newly diagnosed AML by randomised evaluation of: 1. Standard dose (100 mg/m2 b.d.) versus higher dose (200mg/m2 b.d.) Ara-C within a DAT (daunorubicin, Ara-C, thioguanine) induction regimen (courses 1 and 2) 2. The addition of retinoic acid (ATRA) during and after induction chemotherapy (courses 1 and 2) 3. Four versus five courses of therapy in total (where the final course is either chemotherapy or transplant) 4. Bone marrow transplantation (BMT) (either allogenic or autologous) versus conventional chemotherapy as the final course (good risk patients should not be entered into this randomisation). The therapeutic relevance of morphology, cytogenetics, molecular genetics and immunophenotype will also be investigated.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Leukaemia
Intervention	Four randomised comparisons: 1. S-DAT versus H-DAT 2. All-trans retinoic acid (ATRA) versus control 3. 4 versus 5 courses of therapy in total 4. Bone Marrow Transplant (BMT) versus chemotherapy as the final course
Intervention type	Other
Primary outcome measure(s)	Survival; complete remission (CR) rates and reason for failure; duration of remission; toxicity; quality of life; supportive care requirements.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Key inclusion criteria	1. Acute myeloid leukaemia (AML) (any type of de novo or secondary AML, including acute promyelocytic leukemia [APL]) 2. Suitable for intensive therapy 3. Normally under the age of 60 years (but older patients can be entered if considered suitable) 4. Informed consent given
Key exclusion criteria	1. Previous cytotoxic therapy for leukaemia 2. Concurrent active malignancy 3. Blast transformation of CML 4. Pregnant or lactating 5. Intensive chemotherapy not considered to be an appropriate treatment option 6. Patients with APL are not eligible for the ATRA randomisation
Date of first enrolment	01/10/1994
Date of final enrolment	01/01/2001

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Department of Haematology

Cardiff
CF14 4XN
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	15/09/2001		Yes	No
Results article	results	15/11/2005		Yes	No
Results article	results	04/02/2010		Yes	No
Results article	results	01/04/2013		Yes	No
Results article	results	10/07/2014		Yes	No
Results article	results	01/01/2018	25/07/2019	Yes	No
Plain English results				No	Yes

Editorial Notes

25/07/2019: Publication reference added.
18/10/2018: Cancer Research UK lay results summary link added to Results (plain English)