Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00162656
Protocol/serial number
NHL9603
Study information
Scientific title
Randomized 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.
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Lymphoma (non-Hodgkins), leukaemia (acute)
Intervention
1. 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 type
Drug
Phase
Not Specified
Drug names
Cyclophosphamide, vincristine, prednisolone (COP)
Cyclophosphamide, vincristine, prednisolone, adriamycin, hydrocortisone and methotrexate (COPADM).
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1997
Overall trial end date
15/06/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1997
Recruitment end date
15/06/2001
Locations
Countries of recruitment
France, United Kingdom, United States of America
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
United Kingdom Children's Cancer Study Group (UKCCSG)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2007 results in https://www.ncbi.nlm.nih.gov/pubmed/17132719 (added 25/01/2019)