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

ISRCTN ISRCTN64649191
DOI https://doi.org/10.1186/ISRCTN64649191
ClinicalTrials.gov number NCT00003436
Secondary identifying numbers G8223452
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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymAML 12
Study objectivesTo 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) studiedLeukaemia
InterventionADE/MAE
Intervention typeOther
Primary outcome measureAchievement and duration of remission, survival, febrile incidents, toxicity including cardiotoxicity, supportive care requirements and long-term outcome.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/1995
Completion date01/01/2002

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit16 Years
SexBoth
Target number of participants2,000
Key inclusion criteria1. 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 criteria1. 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 enrolment01/04/1995
Date of final enrolment01/01/2002

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Department of Haematology
Glasgow
G3 8SJ
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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