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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN55678797 |
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Date of registration:
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19/08/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Acute Myeloid Leukaemia (AML) Trial 12 (modified) for patients aged under 60
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Scientific title:
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Date of first enrolment:
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01/11/1998 |
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Target sample size:
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500 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN55678797 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Affiliation:
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Name:
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-
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Address:
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
NW1 2DA
London
United Kingdom |
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Leukaemia (acute)
Cancer
Leukaemia
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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Not provided at time of registration
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Secondary ID(s)
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MRC AML12 (modified)
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Source(s) of Monetary Support
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Medical Research Council (MRC) (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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