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| Acute Myeloid Leukaemia (AML) Trial 12 (modified) for patients aged under 60 |
| Source of record | UK Trials |
| ISRCTN | ISRCTN55678797 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | MRC AML12 (modified) |
| Public title | Acute Myeloid Leukaemia (AML) Trial 12 (modified) for patients aged under 60 |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Leukaemia (acute) |
| Study hypothesis | Added as of 07/03/2007: To compare two methods of administering all-Trans Retinoic Acid (ATRA) to patients with acute promyelocytic leukaemia (APL, FAB AML-M3) - either ATRA for 5 days only before the introduction of trial induction chemotherapy or continuous ATRA during induction chemotherapy until complete remission is achieved (or for a maximum of 60 days) with respect to differences in haemorrhagic complications, induction deaths, remission rate, remission duration and overall survival. To evaluate the role of ATRA in correcting the coagulopathy associated with APL. - To investigate the two methods of using ATRA therapy with respect to the sequence of change of laboratory parameters of coagulation and thrombolysis, and blood product usage. To evaluate cytogenetic and molecular monitoring of disease status with reference to the prediction of morphological leukaemia relapse. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 01/11/1998 |
| Anticipated end date | 01/11/2003 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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 |
| Primary outcome measure(s) | 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. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Medical Research Council (UK) |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent London United Kingdom W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.ac.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator MRC Clinical Trials Unit 222 Euston Road London United Kingdom NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN55678797 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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