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
Scientific
Department of Haematology
Royal Hospital for Sick Children
Yorkhill
Glasgow
G3 8SJ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | 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 study start date | 01/04/1995 |
| Completion date | 01/01/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 2,000 |
| 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
- Scotland
- United Kingdom
Study participating centre
Department of Haematology
Glasgow
G3 8SJ
United Kingdom
G3 8SJ
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| 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
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
