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| [ Print-friendly version ] |
| National Cancer Research Institute acute myeloid leukaemia and high risk MDS trial 16. A trial for older patients with acute myeloid leukaemia and high risk myelodysplastic syndrome (MDS). |
| ISRCTN | ISRCTN11036523 |
| ClinicalTrials.gov identifier | NCT00454480 |
| Public title | National Cancer Research Institute acute myeloid leukaemia and high risk MDS trial 16. A trial for older patients with acute myeloid leukaemia and high risk myelodysplastic syndrome (MDS). |
| Scientific title | |
| Acronym | AML16 |
| Serial number at source | NA |
| Study hypothesis |
Current study hypothesis as of 04/08/2011:
Therapeutic questions for patients considered fit for intensive treatment: 1. To compare two induction schedules (DA and ADE) 2. To assess the value of ATRA during induction when used in combination with DA or ADE for the first 50 days 3. To compare a total of two versus three courses of treatment in patients who achieve at least Partial Remission (<15% blasts) after induction course 1 4. To compare the use of Demethylation maintenance treatment with Azacytidine with no maintenance 5. To assess the value of Reduced Intensity Allogeneic Stem Cell Transplantation as consolidation for patients with matched donors Therapeutic questions for patients not considered fit for intensive treatment: To compare Low Dose Ara-C versus Sapacitabine. Previous options, including clofarabine, have now been completed. As of 15/02/2011 the anticipated end date for this trial has been updated from 01/10/2010 to 31/08/2011. As of 22/07/2011 the end date has again been extended to 01/01/2012. Previous study hypothesis points: 1. To compare two induction schedules (DA and DClo) 2. To assess the value of ATRA during induction when used in combination with DA or DClo in course 1 Therapeutic questions for patients not considered fit for intensive treatment: To compare Low Dose Ara-C versus available novel approaches: Low Dose Ara-C with Mylotarg, Low Dose Ara-C with Zarnestra, Low Dose Clofarabine. During the course of the Programme other novel therapies are expected to become available, and will be considered for inclusion in this comparison. |
| Lay summary |
http://www.cancerhelp.org.uk/trials/a-trial-looking-at-treatment-for-acute-myeloid-leukaemia-and-high-risk-myelodysplastic-syndrome-intensive-treatment-group
http://www.cancerhelp.org.uk/trials/a-trial-looking-at-treatment-for-acute-myeloid-leukaemia-and-high-risk-myelodysplastic-syndrome-non-intensive-treatment-group |
| Ethics approval |
MREC for Wales on 16/12/2005 (ref: 05/MRE09/84)
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| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Acute Myloid Leukaemia (AML) and High Risk Myelodysplastic Syndrome (MDS). |
| Participants - inclusion criteria |
1. They have one of the forms of acute myeloid leukaemia, except acute promyelocytic leukaemia, as defined by the World Health Organisation (WHO) Classification - this can be any type of de novo or secondary AML - or high risk Myelodysplastic Syndrome, defined as greater than 10% marrow blasts (RAEB-2)
2. They should normally be over the age of 60, but patients under this age are eligible if they are not considered fit for the MRC AML 15 trial 3. They have given written informed consent |
| Participants - exclusion criteria |
1. Patients have previously received cytotoxic chemotherapy for AML. (Hydroxyurea, or similar low-dose therapy, to control the white count prior to initiation of intensive therapy is not an exclusion.)
2. They are in blast transformation of chronic myeloid leukaemia (CML) 3. They have a concurrent active malignancy 4. They are pregnant or lactating 5. Patients with abnormal liver function tests exceeding twice the local upper limit of normal are not eligible for the Mylotarg randomisations 6. Patients with Acute Promyelocytic Leukaemia |
| Anticipated start date | 01/10/2005 |
| Anticipated end date | 01/01/2012 |
| Status of trial | Completed |
| Patient information material | Patient information can be found at: http://www.aml16.bham.ac.uk/Trial/2st%20Amendment%20May%202006/AML16%20PIS%201%20version%204%20May%202006%20tracked%20changes%20accepted.doc |
| Target number of participants | 2500 (or until all relevant questions have been answered) |
| Interventions |
Current interventions as of 04/08/2011:
Intensive interventions: There are three randomised comparisons within the trial: At diagnosis: i. DA versus ADE ii. ATRA versus not for 60 days As consolidation: i. Three courses versus two courses of total induction/consolidation therapy ii. Non-intensive allogeneic stem cell transplant for patients with donors As maintenance: i. Azacytidine or not for one year Non-Intensive interventions: Low Dose Ara-C versus Low Dose Clofarabine* OR Sapacitabine. *Clofarabine option now closed. For each of these non-intensive options the treatment plan is for four courses to be given. Marrow response should be assessed before each course until complete remission is established. Previous interventions: At diagnosis: i. DA versus DClo ii. Mylotarg versus not in Course 1 for 60 days Non-Intensive interventions: Low Dose Ara-C versus Low Dose Ara-C with Mylotarg OR Low Dose Clofarabine OR Low Dose Ara-C with Zarnestra |
| Primary outcome measure(s) |
For intensive treatment:
Overall survival, complete remission (CR) achievement and reasons for failure (for induction questions), duration of remission, relapse rates and deaths in 1st CR. For non–intensive treatments: Overall survival, including survival at 6 months for the initial assessment of whether to continue with a novel therapy. |
| Secondary outcome measure(s) |
For intensive treatment:
Toxicity as assessed by NCI/WHO definitions; days to haematological recovery; supportive care requirements (days on antibiotics, days in hospital, blood product support). For non-intensive treatment: Toxicity as assessed by NCI/WHO definitions; days to haematological recovery; supportive care requirements (days on antibiotics, days in hospital, blood product support); complete remission (CR) achievement and reasons for failure, duration of remission, relapse rates and deaths in 1st CR. |
| Sources of funding | Clinical Trials Advisory and Awards Committee (CTAAC). Ref. No. C4999/A6031. |
| Trial website | http://www.aml16.bham.ac.uk |
| Publications | |
| Contact name | Prof Alan Burnett |
| Address |
Department of Haematology
University of Wales College of Medicine Heath Park |
| City/town | Cardiff |
| Zip/Postcode | CF14 4XN |
| Country | United Kingdom |
| Tel | +44 (0)29 2074 2375 |
| Fax | +44 (0)29 2074 4655 |
| BurnettAK@Cardiff.ac.uk | |
| Sponsor | Cardiff University (UK) |
| Address |
Department of Haematology
University of Wales College of Medicine Heath Park |
| City/town | Cardiff |
| Zip/Postcode | CF14 4XN |
| Country | United Kingdom |
| Tel | +44 (0)29 2074 2375 |
| Fax | +44 (0)29 2074 4655 |
| BurnettAK@Cardiff.ac.uk | |
| Date applied | 17/08/2005 |
| Last edited | 04/08/2011 |
| Date ISRCTN assigned | 11/10/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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