UKALL R2 - Acute Lymphoblastic Leukaemia trial
| ISRCTN | ISRCTN95257778 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95257778 |
| Protocol serial number | G8223452 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | UK Medical Research Council |
- Submission date
- 06/04/2000
- Registration date
- 06/04/2000
- Last edited
- 04/10/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr PJ Darbyshire
Scientific
Scientific
The Children's Hospital
Ladywood Middleway
Birmingham
B16 8ET
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | UKALL R2 |
| Study objectives | To compare continuing chemotherapy with unrelated donor BMT in relapsed childhood ALL following a common re-induction and consolidation regimen. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Acute Lymphoblastic Leukaemia |
| Intervention | Continuing chemotherapy/unrelated donor BMT |
| Intervention type | Other |
| Primary outcome measure(s) |
Survival, disease free survival |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 200 |
| Key inclusion criteria | They are children under 15 years at original diagnosis and treated on UKALL trials or pilot studies with first relapse less than 4 years from the start of treatment of ALL at any site and no suitable related bone marrow treatment (BMT) donor is available |
| Key exclusion criteria | 1. They are multiply relapsed patients 2. They have a prior history of toxicity or organ damage such that completion of the protocol is felt unlikely at the outset 3. They have had an isolated CNS or testicular relapse more than 6 months off treatment. |
| Date of first enrolment | 01/02/1995 |
| Date of final enrolment | 30/09/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The Children's Hospital
Birmingham
B16 8ET
United Kingdom
B16 8ET
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/07/2005 | Yes | No |
