Medical Research Council Acute Lymphoblastic Leukaemia Trial in Children UKALL R1

ISRCTN ISRCTN13327255
DOI https://doi.org/10.1186/ISRCTN13327255
Secondary identifying numbers MRC UKALL R1
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

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesNot provided at time of registration.
Ethics approval(s)Local research ethics committee approval.
Health condition(s) or problem(s) studiedLeukaemia (acute)
InterventionINDUCTION 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 typeOther
Primary outcome measureNot provided at time of registration.
Secondary outcome measuresNot provided at time of registration.
Overall study start date01/02/1991
Completion date30/04/1995

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants256 patients were recruited.
Key inclusion criteria1. 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 criteriaNot provided at time of registration.
Date of first enrolment01/02/1991
Date of final enrolment30/04/1995

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Government

Medical Research Council (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom
European Organisation for Research and Treatment of Cancer (EORTC)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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