| Source of record | UK Trials |
| ISRCTN | ISRCTN46123985 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | CML IIIB |
| Public title | Trial of alpha-interferon in chronic myeloid leukaemia and a comparison of busulphan and hydroxyurea for induction and maintenance |
| 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. Aged over 75 years with either Ph positive or Ph negative chronic myeloid leukaemia in chronic phase. Patients over 75 years or patients unwilling to accept alpha-interferon, may be randomised to busulphan or hydroxyurea, but not interferon or no interferon
2. Adequate renal function
3. No severe concurrent hepatic, renal, cardiovascular, organic brain disease or psychiatric illness
4. Patients with established blast cell crisis or extramedullary granulocytic sarcomas are to be excluded
5. Patients with accelerated phase or platelet count below that specified in the protocol are not eligible |
| Participants - exclusion criteria | Not provided at time of registration. |
| Patient information material |
|
| Anticipated start date | 01/08/2000 |
| Anticipated end date | 01/08/2005 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration. |
| Interventions | There are four treatment arms, clinicians may choose to randomise between only arms 1 and 2, 3 and 4, 2 and 4 or to randomise between all treatment arms.
1. Regimen A: Induction therapy with busulphan followed by maintenance therapy with busulphan plus alpha-interferon.
2. Regimen B: Induction therapy with busulphan followed by maintenance therapy with busulphan only.
3. Regimen C: Induction therapy with hydroxyurea followed by maintenance therapy with hydroxyurea plus alpha-interferon.
4. Regimen D: Induction therapy with hydroxyurea followed by maintenance therapy with hydroxyurea only. |
| Primary outcome measure(s) | Not provided at time of registration. |
| Secondary outcome measure(s) | Not provided at time of registration. |
| Sources of funding | UK Medical Research Council |
| 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 | ISRCTN46123985 |
| Date last extracted from ISRCTN register | 17/04/2008 |
