|
Welcome
|
|
21 March 2013
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Acute Myeloid Leukaemia - High Risk (AML-HR) |
| ISRCTN | ISRCTN88373119 |
| DOI | 10.1186/ISRCTN88373119 |
| ClinicalTrials.gov identifier | NCT00005863 |
| EudraCT number | |
| Public title | Acute Myeloid Leukaemia - High Risk (AML-HR) |
| Scientific title | |
| Acronym | AML-HR |
| Serial number at source | G9800529 |
| Study hypothesis |
To improve the outcome of patients with high risk AML by randomised evaluation of:
1. The standard ADE (Ara-C,daunorubicin, etoposide) reinduction regimen versus the newer FLA (fludarabine, high-dose Ara-C) regimen 2. The addition of growth factor (G-CSF) during and after chemotherapy. 3. The addition of retinoic acid (ATRA) during and after chemotherapy. Patients may be entered into all three randomisations, any combination of two randomisations, or just one randomisation. The therapeutic relevance of morphology, genetics and other features will also be investigated. |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Leukaemia |
| Participants - inclusion criteria |
1. High risk acute myeloid leukaemia (AML) (de novo or secondary, except acute promyelocytic leukemia [APL])
2. Suitable for intensive therapy 3. Informed consent given. High risk AML is defined as: (a) Resistant disease (greater than 15% blasts in bone marrow) after one induction course (b) Refractory disease (ie not in complete remission [CR]) after two or more induction courses (c) Relapse from first CR (with more than 5% blasts in bone marrow) (d) In complete or partial remission after one induction course but with adverse cytogenic abnormalities at diagnosis |
| Participants - exclusion criteria |
1. APL
2. Concurrent active malignancy 3. Blast transformation of CML 4. Relapse from second or greater CR 5. Severe renal impairment (creatinine clearance less than 30 millilitres per minute) 6. Pregnant, lactating or potentially fertile and not taking adequate contraceptive precautions |
| Anticipated start date | 01/11/1998 |
| Anticipated end date | 31/12/2004 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 600 |
| Interventions |
Three randomised comparisons:
1. ADE versus FLA 2. Granulocyte Colony Stimulating Factor (G-CSF) versus control 3. All-trans-retinoic acid (ATRA) versus control Follow-up until death. |
| Primary outcome measure(s) |
1. Survival
2. Complete remission (CR) rates and reason for failure 3. Duration of remission 4. Toxicity 5. Quality of life 5. Supportive care requirements |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Medical Research Council (UK) |
| Trial website | |
| Publications | Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=16484584 |
| Contact name | Dr DW Milligan |
| Address |
Department of Haematology
Birmingham Heartlands Hospital Bordesley Green East |
| City/town | Birmingham |
| Zip/Postcode | B9 5SS |
| Country | United Kingdom |
| Tel | +44 (0)121 424 3699 |
| Fax | +44 (0)121 766 7530 |
| d.w.milligan@bham.ac.uk | |
| Sponsor | Medical Research Council (MRC) (UK) |
| Address | 20 Park Crescent |
| City/town | London |
| Zip/Postcode | W1B 1AL |
| Country | United Kingdom |
| Tel | +44 (0)20 7636 5422 |
| Fax | +44 (0)20 7436 6179 |
| clinical.trial@headoffice.mrc.ac.uk | |
| Sponsor website: | http://www.mrc.ac.uk |
| Date applied | 25/10/2000 |
| Last edited | 12/09/2007 |
| Date ISRCTN assigned | 25/10/2000 |
|
|
|
|
|
| © 2013 ISRCTN unless otherwise stated. | |
|
