Medical Research Council Adult Acute Lymphoblastic Leukaemia Trial UKALL XA
| ISRCTN | ISRCTN35362654 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35362654 |
| Protocol serial number | MRC UKALL XA |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 07/06/2012
- 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 |
| Study type | Participant information sheet |
| Scientific title | |
| 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 (acute) |
| Intervention | All patients receive induction, central nervous system (CNS) prophylaxis and maintenance. Patients are randomised to one of four treatment arms: 1. Arm A: Early intensification therapy to be given immediately after induction and before CNS prophylaxis. 2. Arm B: Late intensification therapy to be given following cranial radiotherapy at week 20 of maintenance. 3. Arm C: Intensification therapy to be given both immediately after induction and following cranial radiotherapy at week 20 of maintenance. 4. Arm D: No intensification therapy. INDUCTION: Chemotherapy with vincristine, prednisolone, asparaginase, daunorubicin and intrathecal methotrexate. INTENSIFICATION: Intensification therapy with vincristine, prendisolone, daunorubicin, thioguanine, etoposide, cytosine arabinoside and intrathecal methotrexate. CNS PROPHYLAXIS: Cranial radiotherapy, intrathecal methotrexate plus mercaptopurine. MAINTENANCE: Maintenance therapy consisting of daily mercaptopurine, weekly methotrexate, monthly vincristine plus prednisolone. Treatment to be given for total of two years following complete remission. |
| 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 | 31/12/1992 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 618 |
| Key inclusion criteria | 1. Newly diagnosed ALL 2. Aged >25 years |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/01/1985 |
| Date of final enrolment | 31/12/1992 |
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 | 01/10/1997 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
