Medical Research Council/ European Blood and Marrow Transplant Prospective Randomised Trial of Autograft in Chronic Myeloid Leukaemia (CML)
| ISRCTN | ISRCTN53369512 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53369512 |
| Secondary identifying numbers | MRC CML 2000 (IVa) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 26/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Stopped
- 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
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Medical Research Council/ European Blood and Marrow Transplant Prospective Randomised Trial of Autograft in Chronic Myeloid Leukaemia (CML) |
| Study objectives | Not provided at time of registration. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Leukaemia (chronic) |
| Intervention | 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). |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration. |
| Secondary outcome measures | Not provided at time of registration. |
| Overall study start date | 01/10/1996 |
| Completion date | 30/10/2001 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Not provided at time of registration. |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/10/1996 |
| Date of final enrolment | 30/10/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
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
Not defined
European Bone Marrow Transplantation Group
No information available
Medical Research Council (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 |
Editorial Notes
26/03/2020: Trial status changed to stopped due to poor accrual.
