Plain English Summary
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
MRC AML12 (modified)
Study information
Scientific title
Acronym
Study hypothesis
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.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Overall study end date
01/11/2003
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Sex
Not Specified
Target number of participants
500
Participant 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
Recruitment start date
01/11/1998
Recruitment end date
01/11/2003
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
UK Medical Research Council, MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
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 |