Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
03/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

- - -

ORCID ID

Contact details

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

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 measures

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

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

http://www.cancer.org.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes