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 |
| Protocol serial number | MRC CML 2000 (IVa) |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funders | European Bone Marrow Transplantation Group, Medical Research Council (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial. |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Not provided at time of registration. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 30/10/2001 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| 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
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
26/03/2020: Trial status changed to stopped due to poor accrual.
