Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00162656
Protocol/serial number
NHL9602
Study information
Scientific title
Treatment of mature B-cell lymphoma/leukaemia
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
Leukaemia (acute), lymphoma (non-Hodgkin's)
Intervention
Patients are randomised to one of four treatment arms:
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) followed by cytarabine, etoposide and a third course of COPADM
2. Arm 2: A single course of COP followed by two courses of COPADM then cytarabine followed by etoposide
3. Arm C: A single course of COP followed by two courses of modified COPADM in which the dose of cyclophosphamide has been halved. Patients then receive cytarabine followed by etoposide and a third course of COPADM
4. Arm D: A single course of COP followed by two courses of modified COPADM in which the dose of cyclophosphamide has been halved. Patients then receive cytarabine followed by etoposide
Intervention type
Drug
Phase
Not Applicable
Drug names
Cyclophosphamide, vincristine, prednisolone, adriamycin, hydrocortisone, methotrexate, cytarabine, etoposide
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1998
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
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1998
Recruitment end date
15/06/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
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)