Medical Research Council Acute Lymphoblastic Leukaemia Trial in Children UKALL R1
| ISRCTN | ISRCTN13327255 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13327255 |
| Protocol serial number | MRC UKALL R1 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funders | Medical Research Council (UK), European Organisation for Research and Treatment of Cancer (EORTC) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 20/06/2012
- 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 - -
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 | |
| Study objectives | Not provided at time of registration. |
| Ethics approval(s) | Local research ethics committee approval. |
| Health condition(s) or problem(s) studied | Leukaemia (acute) |
| Intervention | INDUCTION THERAPY: All patients receive induction chemotherapy with allopurinol, dexamethasone, vincristine, aspariganase and etoposide plus intrathecal methotrexate, cystarabine and hydrocortisone. CONSOLIDATION THERAPY: Patients receive consolidation therapy with etoposide, cytarabine and intrathecal methotrexate followed by dexamethosone, asparaginase, epirubicin and vincristine then thioguanine, cytarabine, cyclophosphamide and intrathecal methotrexate. CONTINUATION THERAPY: Following consolidation patients are treated according to their initial randomisation: 1. Regimen A: A marrow-ablative regimen of cyclophosphamide and allopurin plus total body irradiation followed by autologous Bone Marrow Transplant (BMT) or allogenic BMT. 2. Regimen B: High dose methotrexate followed by continuation treatment with prednisolone, vincristine, mercaptopurine, methotrexate, thioguanine, etoposide, cytarabine, cyclophosphamide and intrathecal methotrexate. The duration of therapy is eight cycles each taking 9 weeks. |
| 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 | 30/04/1995 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 256 |
| Key inclusion criteria | 1. Children under the age of 25 years at original diagnosis with first relapse of ALL at any site from previous UKALL trials or pilot studies 2. Multiple relapsed patients are excluded 3. Patients with prior history of toxicity or organ damage such that completion of the protocol is felt unlikely at the outset are to be excluded 4. Patients with Central Nervous System (CNS) relapse must have had prior radiotherapy |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/02/1991 |
| Date of final enrolment | 30/04/1995 |
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2000 | Yes | No |
