CML IV - Chronic phase chronic myeloid leukaemia/CML 2000
| ISRCTN | ISRCTN61147621 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61147621 |
| Secondary identifying numbers | G8223452 |
- Submission date
- 25/10/2000
- Registration date
- 25/10/2000
- Last edited
- 15/08/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof I Franklin
Scientific
Scientific
Academic Transfusion Medicine Unit, Cancer Division
Section of Experimental Haematology
Glasgow Royal Infirmary
10 Alexandra Parade
Glasgow
G31 2ER
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | CML 2000 |
| Study objectives | To improve on the best current therapy in chronic phase CML for patients who do not undergo allogeneic BMT with respect to prolonging survival. The trial will compare the combination of a cycle of chemotherapy and an autograft with subsequent alpha IFN with alpha IFN therapy alone. Also, to compare whether low dose alpha IFN therapy is as effective as high dose alpha IFN therapy. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Leukaemia |
| Intervention | Cycle of chemotherapy and an autograft with subsequent IFN/IFN therapy alone |
| Intervention type | Other |
| Primary outcome measure | Length of survival, quality of life, cytogenetic response |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1996 |
| Completion date | 31/10/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Not Specified |
| Target number of participants | 800 |
| Key inclusion criteria | 1. The interval from diagnosis to registration does not exceed 3 months (if received only hydroxyurea in these 3 months proceed to register, if alpha Interferon (IFN) has been given contact co-ordinators) 2. They are aged 18-60; they have newly diagnosed CML 3. They have acceptable criteria for chronic phase 4. They have given informed consent and are willing to be randomised, there is no contraindication to collection of blood or marrow progenitor cells before treatment is commenced 5. They are not pregnant |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1996 |
| Date of final enrolment | 31/10/2001 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Academic Transfusion Medicine Unit, Cancer Division
Glasgow
G31 2ER
United Kingdom
G31 2ER
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
