|
ISRCTN
|
ISRCTN17584197
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Treatment of mature B-cell lymphoma/leukaemia
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
NHL9603
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom, international
|
|
Disease/condition/study domain
|
Lymphoma (non-Hodgkins), leukaemia (acute)
|
|
Participants - 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
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/01/1997
|
|
Anticipated end date
|
15/06/2001
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
1. Cancer Research UK
2. United Kingdom Children's Cancer Study Group (UKCCSG)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
-
-
|
|
Address
|
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0) 20 7670 4723
|
|
Fax
|
+44 (0) 20 7670 4818
|
|
Email
|
register@ctu.mrc.ac.uk
|
|
Sponsor
|
Cancer Research UK (CRUK) (UK)
|
|
Address
|
PO Box 123
Lincoln's Inn Fields
|
|
City/town
|
London
|
|
Zip/Postcode
|
WC2A 3PX
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7317 5186
|
|
Fax
|
+44 (0)20 7487 4302
|
|
Email
|
kate.law@cancer.org.uk
|
|
Sponsor website:
|
http://www.cancer.org.uk
|
|
Date applied
|
01/07/2001
|
|
Last edited
|
17/12/2007
|
|
Date ISRCTN assigned
|
01/07/2001
|
