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ISRCTN
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ISRCTN17833622
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DOI
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10.1186/ISRCTN17833622
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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AML 12 - Acute myeloid leukaemia Adults (modified)
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Scientific title
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Acronym
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AML 12
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Serial number at source
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G8223452
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Leukaemia
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/10/1994
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Anticipated end date
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01/01/2001
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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
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Primary outcome measure(s)
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Survival; complete remission (CR) rates and reason for failure; duration of remission; toxicity; quality of life; supportive care requirements.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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1. 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11535508
2. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16076872
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19965647
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Contact name
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Prof
AK
Burnett
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Address
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Department of Haematology
University of Wales College of Medicine
Heath Park
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City/town
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Cardiff
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Zip/Postcode
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CF14 4XN
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Country
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United Kingdom
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Tel
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+44 (0)29 2074 2375
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Fax
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+44 (0)29 2074 4655
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Email
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burnettak@cardiff.ac.uk
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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25/10/2000
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Last edited
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09/03/2010
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Date ISRCTN assigned
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25/10/2000
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