Acute Myeloid Leukaemia (AML) Trial 12 (modified) for patients aged under 60
| ISRCTN | ISRCTN55678797 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55678797 |
| Secondary identifying numbers | MRC AML12 (modified) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 30/05/2012
- 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
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Added as of 07/03/2007: To compare two methods of administering all-Trans Retinoic Acid (ATRA) to patients with acute promyelocytic leukaemia (APL, FAB AML-M3) - either ATRA for 5 days only before the introduction of trial induction chemotherapy or continuous ATRA during induction chemotherapy until complete remission is achieved (or for a maximum of 60 days) with respect to differences in haemorrhagic complications, induction deaths, remission rate, remission duration and overall survival. To evaluate the role of ATRA in correcting the coagulopathy associated with APL. - To investigate the two methods of using ATRA therapy with respect to the sequence of change of laboratory parameters of coagulation and thrombolysis, and blood product usage. To evaluate cytogenetic and molecular monitoring of disease status with reference to the prediction of morphological leukaemia relapse. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Leukaemia (acute) |
| Intervention | Four randomised comparisons: At diagnosis: 1. S-DAT versus H-DAT 2. All-trans-retinoic acid (ATRA) versus not (except for acute promyelocytic leukaemia (APL) patients who will receive ATRA) After course 3: 3. 4 versus 5 courses of total therapy 4. Bone marrow transplant (BMT) versus chemotherapy as the final course of therapy Added 08/09/09: A trial with 250 patients would have a power of 50% to detect (at 2p=0.05) a 10% absolute difference in remission rate or long term survival between the two ATRA groups. If no difference were apparent between the two arms the possibility that one arm is greatly superior to the other (ie more than 50% better) would be eliminated. With extended collaboration (UK and internationally) to recruit a total of 500 patients the trial would have a power of about 90% to detect a 10% difference in remission rate and a power of about 50% to detect a 5% difference. |
| Intervention type | Other |
| Primary outcome measure | Added as of 07/03/2007: Haemorrhagic complications, induction deaths, remission rate, remission duration, overall survival and the role of ATRA in correcting the coagulopathy associated with APL. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/11/1998 |
| Completion date | 01/11/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 500 |
| Key inclusion criteria | 1. Have one of the forms of AML 2. Are considered suitable for intensive chemotherapy 3. Are normally under the age of 60 years, but can be older as long as intensive therapy is considered suitable 4. Have given written informed consent |
| Key exclusion criteria | Added as of 07/03/2007: 1. Previously received any treatment for APL 2. Other forms of AML (including CML in promyelocytic blast crisis) 3. Another concurrent active malignancy 4. Pregnant or consider the possibility of becoming pregnant during the course of treatment |
| Date of first enrolment | 01/11/1998 |
| Date of final enrolment | 01/11/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
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? |
|---|---|---|---|---|---|
| Results article | results on FLT3 duplication as a prognostic risk factor in chemotherapy | 15/09/2001 | Yes | No | |
| Results article | results on relationships between age at diagnosis, clinical features, and outcome of therapy | 15/09/2001 | Yes | No | |
| Results article | results | 15/11/2005 | Yes | No | |
| Results article | results | 01/03/2006 | Yes | No | |
| Results article | results | 01/02/2010 | Yes | No | |
| Other publications | pooled analysis of prognostic significance of rare recurring chromosomal abnormalities | 22/07/2010 | Yes | No |
