Condition category
Cancer
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
14/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr BEG Gibson

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00003436

Protocol/serial number

G8223452

Study information

Scientific title

Acronym

AML 12

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Leukaemia

Intervention

ADE/MAE

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Achievement and duration of remission, survival, febrile incidents, toxicity including cardiotoxicity, supportive care requirements and long-term outcome.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/1995

Overall trial end date

01/01/2002

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

2,000

Participant 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.

Recruitment start date

01/04/1995

Recruitment end date

01/01/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Haematology
Glasgow
G3 8SJ
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16304572

Publication citations

  1. Results

    Gibson BE, Wheatley K, Hann IM, Stevens RF, Webb D, Hills RK, De Graaf SS, Harrison CJ, Treatment strategy and long-term results in paediatric patients treated in consecutive UK AML trials., Leukemia, 2005, 19, 12, 2130-2138, doi: 10.1038/sj.leu.2403924.

Additional files

Editorial Notes