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| AML17: A programme of treatment development in younger patients with Acute Myeloid Leukaemia and high risk myelodysplasyic syndrome |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN55675535 |
| Date ISRCTN assigned | 02/07/2007 |
| Local reference number(s) | CU 372-07 |
| Public title | AML17: A programme of treatment development in younger patients with Acute Myeloid Leukaemia and high risk myelodysplasyic syndrome |
| Scientific title | |
| Acronym | AML17 |
| Disease/condition/study domain | Acute myeloid leukaemia / high risk myelodysplastic syndrome |
| Study hypothesis | Best chemotherapy +/- molecular intervention and risk directed chemotherapy. |
| Design/methodology | Randomised controlled trial. |
| Research ethics review | To be applied for |
| Countries of trial | United Kingdom and Denmark. |
| Participants - inclusion criteria | 1. They have one of the forms of AML as defined by the WHO 2. They are considered suitable for intensive chemotherapy 3. They are <60 years 4. For Mylotarg (gemtuzumab ozogamicin) intervention, have liver function tests within twice the upper limit of normal |
| Participants - exclusion criteria | 1. No previous cytotoxic therapy for AML other than hydroxyurea 2. Blast transformation of Chronic Myeloid Leukemia (CML) 3. Concurrent active malignancy 4. Pregnant or lactating 5. Children with Downs Syndrome |
| Patient information material | |
| Anticipated start date | 01/10/2007 |
| Anticipated end date | 01/08/2012 |
| Status of trial | Ongoing |
| Target number of participants | 2500 |
| Interventions | 1. In Acute Promyelocytic Leukaemia (APL) patients to compare idarubicin + All-Trans Retinoic Acid (ATRA) vs ATRA + arsenic 2. In non-APL patients to compare ADE alone vs ADE or DA each with Mylotarg at two different doses (5 arms): 2.1. ADE alone 2.2. ADE + Mylotarg (3 mg) 2.3. DA + Mylotarg (3 mg) 2.4. ADE + Mylotarg (6 mg) 2.5. DA + Mylotarg (6 mg) 3. Three vs four courses of total therapy 4. +/- CEP-701 (lestaurtinib) in FLT3 mutants 5. Dauno + clofarabine vs dauno + cloretazine vs fludarabine, cytarabine, granulocyte colony-stimulating factor, and idarubicin (FLAG-Ida) in high risk patients 6. +/- mTOR inhibition in non-CBF, non-FLT3 mutant, in non-high risk patients The treatment period is approximately 4 to 6 months. |
| Primary outcome measure(s) | 1. Complete Remission (CR), measured at approximately 1 month and if required approximately 6 weeks later i.e. after course 1 and/or 2. 2. CR duration 3. Relapse rate, monitored over 5 years 4. Deaths in CR monitored over 5 years 5. Overall survival (at 5 years) 6. Toxicity 7. Quality of life, measured at baseline and at 3, 6, 12 and 24 months for those in the APL section of the trial, and at 3, 6 and 12 months for patients in the minimal residual disease monitoring. The European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire for Cancer patients (EORTC QLQC-30) and Hospital Anxiety and Depression Score (HADS) will be used. 8. Supportive care requirements |
| Secondary outcome measure(s) | 1. Detection of minimal residual disease 2. Correlation of serum inhibitory activity |
| Sources of funding | 1. Medical Research Council (decision pending) 2. Cephalon (providing arsenic trioxide and CEP-701) 3. Wyeth (providing Mylotarg® and temsirolimus) 4. Vion (providing cloretazine) 5. Bienvision (providing clofarabine) |
| Sponsor name | Cardiff University (UK) |
| Sponsor details | c/o Dr Kathy Pittard-Davies 33-36 Newport Road Cardiff United Kingdom CF2 |
| Sponsor telephone | +44 29208 79274 |
| Sponsor email | DaviesKP2@Cardiff.ac.uk |
| Sponsor website | http://www.Cardiff.ac.uk |
| Contact name | Prof Alan Burnett |
| Contact details | School of Medicine,Cardiif University, Heath Park Cardiff United Kingdom CF14 4XN |
| Contact telephone | +44 29207 42375 |
| Contact fax | +44 29207 44655 |
| Contact email | BurnettAK@Cardiff.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN55675535 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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