AML 12 - Acute myeloid leukaemia Adults (modified)
| ISRCTN | ISRCTN17833622 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17833622 |
| Secondary identifying numbers | G8223452 |
- 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
Scientific
Department of Haematology
University of Wales College of Medicine
Heath Park
Cardiff
CF14 4XN
United Kingdom
| Phone | +44 (0)29 2074 2375 |
|---|---|
| burnettak@cardiff.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | Survival; complete remission (CR) rates and reason for failure; duration of remission; toxicity; quality of life; supportive care requirements. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/1994 |
| Completion date | 01/01/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| 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
CF14 4XN
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 (MRC) (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? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| 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 |
Editorial Notes
25/07/2019: Publication reference added.
18/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
