| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN53369512 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | MRC CML 2000 (IVa) |
| Public title | Medical Research Council/ European Blood and Marrow Transplant Prospective Randomised Trial of Autograft in Chronic Myeloid Leukaemia (CML) |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Leukaemia (chronic) |
| Study hypothesis | Not provided at time of registration. |
| Design/methodology | Randomised controlled trial. |
| Research ethics review | Not provided at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Newly diagnosed Ph-positive and/or breakpoint cluster region (BCR)-abelson (ABL) positive CML
2. Aged 15-65
3 .Chronic phase disease
4. No contraindication to the collection of peripheral blood progenitor cells before commencing treatment
5. No major organ impairment
6. No pregnancy |
| Participants - exclusion criteria | Not provided at time of registration. |
| Patient information material |
|
| Anticipated start date | 01/10/1996 |
| Anticipated end date | 30/10/2001 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration. |
| Interventions | Two Arms:
1. Control: Interferon (IFN) Starting dose 3 x 10(6) units x 3/week escalating to 5 x 10(6) units/m(2) daily. Adjusted to maintain leukocyte count 2-4 x 10(9)/l. Use of hydroxyurea and/or ara-c optional.
2. Investigational: Mobilised or straight autograft, followed by IFN (+/- Ara-c). |
| Primary outcome measure(s) | Not provided at time of registration. |
| Secondary outcome measure(s) | Not provided at time of registration. |
| Sources of funding | 1. European Bone Marrow Transplantation Group
2. 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 | ISRCTN53369512 |
| Date last extracted from ISRCTN register | 17/04/2008 |
