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

http://cancerhelp.cancerresearchuk.org/trials/aml12-trial-different-chemotherapy-regimes-in-the-treatment-of-acute-myeloid-leukaemia

Contact information

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesAdded 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) studiedLeukaemia (acute)
InterventionFour 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 typeOther
Primary outcome measureAdded 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 measuresNot provided at time of registration
Overall study start date01/11/1998
Completion date01/11/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants500
Key inclusion criteria1. 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 criteriaAdded 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 enrolment01/11/1998
Date of final enrolment01/11/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email 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
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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