ISRCTN ISRCTN17584197
DOI https://doi.org/10.1186/ISRCTN17584197
ClinicalTrials.gov number NCT00162656
Secondary identifying numbers NHL9603
Submission date
01/07/2001
Registration date
01/07/2001
Last edited
25/01/2019
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
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRandomized international FAB/LMB96 trial for intermediate risk B-cell non-Hodgkin lymphoma in children and adolescents: it is possible to reduce treatment for the early responding patients.
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedLymphoma (non-Hodgkins), leukaemia (acute)
Intervention1. Arm A: A single course of cyclophosphamide, vincristine, prednisolone (COP) followed by two courses of chemotherapy with cyclophosphamide, vincristine, prednisolone, adriamycin, hydrocortisone and methotrexate (COPADM). Patients then receive two courses of etoposide alternating with a single dose of methotrexate. This is followed by four courses of maintenance therapy.
2. Arm B: A single course of COP followed by two courses of COPADM. Patients then receive two courses of reduced dose etoposide alternating with a single dose of methotrexate. This is followed by a single course of maintenance therapy.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Cyclophosphamide, vincristine, prednisolone (COP) Cyclophosphamide, vincristine, prednisolone, adriamycin, hydrocortisone and methotrexate (COPADM).
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1997
Completion date15/06/2001

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Months
Upper age limit18 Years
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. B-large cell, small non-cleaved non-Hodgkin's disease or B-cell leukaemia
2. Stages I-IV
3. Aged over 6 months and under 18 years
4. No previous chemotherapy. Emergency radiotherapy or immunotherapy is permitted
5. No congenital immunodeficiency
6. No prior organ transplantation
7. No previous malignancy of any type
8. No medical contraindications to protocol treatments
9. Patients available for a minimal follow-up of 36 months
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1997
Date of final enrolment15/06/2001

Locations

Countries of recruitment

  • England
  • France
  • United Kingdom
  • United States of America

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Phone +44 (0)207 317 5186
Email kate.law@cancer.org.uk
Website http://www.cancer.org.uk
ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom
United Kingdom Children's Cancer Study Group (UKCCSG)

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 01/04/2007 25/01/2019 Yes No

Editorial Notes

25/01/2019: Publication reference added