MRC ALL 97 - UK national lymphoblastic leukaemia (ALL) trial
| ISRCTN | ISRCTN26727615 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26727615 |
| ClinicalTrials.gov (NCT) | NCT00003437 |
| Protocol serial number | G8223452 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 25/10/2000
- Registration date
- 25/10/2000
- Last edited
- 13/08/2009
- 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 C Mitchell
Scientific
Scientific
Consultant Paediatric Oncologist
John Radcliffe Hospital
Headington
Oxford
OX3 9DV
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | MRC ALL 97 |
| Study objectives | To compare, in a randomised fashion the effect on remission rate, event-free survival and overall survival of i) receiving, both during induction and continuing treatment, either oral prednisolone or dexamethasone, ii) receiving, where appropriate and throughout treatment (apart from intensive blocks) either oral 6-mercaptopurine or 6-thioguanine. To assess the effect on event-free survival for all patients of a schedule concentrating on tight control of maintenance therapy. To collect data on i) thiopurine metabolites on serial blood samples to assess the adequacy of therapy and to compare the pharmacokinetics of 6-MP and 6-TG, and ii) the presence or absence of minimal residual disease in serial bone marrow samples to assess its clinical importance. Also, two randomisations will be carried forward from the previous trial (UKALL XI) until sufficient numbers have accrued to answer the questions to which they relate, so subsidiary objectives are i) to continue to study, in a prospective randomised manner, the effect of either two or three blocks of intensive therapy, and ii) to continue to study the effect of high-dose methotrexate or cranial irradiation for patients with presenting white counts in excess of 50 x 10^9/l. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Leukaemia |
| Intervention | Oral prednisolone/dexamethasone/Oral 6-mercaptopurine/6-thioguanine |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Disease-free survival |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 1800 |
| Key inclusion criteria | Open to all children with ALL except those in 'Exclusions' |
| Key exclusion criteria | 1. Patients under 1 year or over 18 years, 2. B-ALL, Ph positivity, near haploidy in blasts or rearrangements involving the MLL gene on 11q23 and 3. High risk by Oxford Hazard Score (based on a function of age, gender and diagnostic leucocyte count) |
| Date of first enrolment | 01/01/1997 |
| Date of final enrolment | 30/06/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Consultant Paediatric Oncologist
Oxford
OX3 9DV
United Kingdom
OX3 9DV
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 | 01/04/2005 | Yes | No |
