Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
20/06/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Simon Menezes

ORCID ID

Contact details

90 Tottenham Court Road
London
W1T 4TJ
United Kingdom
s.menezes@ctc.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

767

Study information

Scientific title

A phase III trial comparing a cyclophosphamide, adriamycin, vincristine and prednisolone (CHOP) regimen to a mitoxantrone, cyclophosphamide, etoposide, bleomycin, vincristine and prednisolone (PMItCEBO) regimen with or without granulocyte colony-stimulating factor (G-CSF) in patients aged sixty years plus with non-hodgkin's lymphoma

Acronym

BNLI 60+

Study hypothesis

1. To compare the efficacy of mitoxantrone, cyclophosphamide, etoposide, bleomycin, vincristine and prednisolone (PMitCEBO) and cyclophosphamide, adriamycin, vincristine and prednisolone (CHOP) using the study endpoints of overall survival, failure free-survival, disease specific survival, disease free survival, complete response (CR) rate, toxic death rate and toxicity
2. To compare the efficacy of the addition of granulocyte colony-stimulating factor (G-CSF) using the endpoints of failure free survival, overall survival, disease specific survival, disease free survival, neutropenia, dose intensity in patient hospitalisation days, toxic death rates and antibiotic use

Ethics approval

Approved by the Human Research Ethics Committees of all participating centres (ref: 98/2/52)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Non-Hodgkin's lymphoma

Intervention

1. CHOP/G-CSF Regimen: chemotherapy with cyclophosphamide, adriamycin, vincristine and prednisolone (CHOP), cycle repeated every 21 days for six to eight cycles plus G-CSF.
2. CHOP Regimen: chemotherapy with CHOP repeated every 21 days for six to eight cycles.
3. PMitCEBO/G-CSF Regimen: Chemotherapy with Mitoxantrone, cyclophosphamide, etoposide, bleomycin, vincristine and prednisolone (PMitCEBO), cycle repeated every 14 days for four to eight cycles plus G-CSF.
4. PMitCEBO Regimen: Chemotherapy MitCEBO, cycle repeated every 14 days for four to eight cycles.

Intervention type

Drug

Phase

Phase III

Drug names

Cyclophosphamide, adriamycin, vincristine and prednisolone (CHOP), mitoxantrone, cyclophosphamide, etoposide, bleomycin, vincristine and prednisolone (PMItCEBO), granulocyte colony-stimulating factor (G-CSF)

Primary outcome measures

Failure free survival

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/1996

Overall trial end date

20/04/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged at least 60 years
2. Newly presenting aggressive non-Hodgkin's lymphoma
3. Bulky stage IA and stages IB - IV
4. Patients must be free from any other irreversible medical condition that would drastically limit their life span or prohibit the use of combination chemotherapy
5. Adequate renal, hepatic and cardiac function
6. No previous malignancy
7. No central nervous system (CNS) involvement with non-Hodgkin's lymphoma

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned sample size: 880

Participant exclusion criteria

Patients with lymphoblastic and Burkitt's lymphoma

Recruitment start date

01/12/1996

Recruitment end date

20/04/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

90 Tottenham Court Road
London
W1T 4TJ
United Kingdom

Sponsor information

Organisation

Lymphoma Research Trust (UK)

Sponsor details

Trustees Department
5th Floor East
250 Euston Road
London
NW1 2PG
United Kingdom

Sponsor type

Charity

Website

http://www.lymphoma-research-trust.org.uk/

Funders

Funder type

Charity

Funder name

Lymphoma Research Trust (UK)

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19450285

Publication citations

  1. Results

    Sharma R, Cunningham D, Smith P, Robertson G, Dent O, Clarke SJ, Inflammatory (B) symptoms are independent predictors of myelosuppression from chemotherapy in Non-Hodgkin Lymphoma (NHL) patients--analysis of data from a British National Lymphoma Investigation phase III trial comparing CHOP to PMitCEBO., BMC Cancer, 2009, 9, 153, doi: 10.1186/1471-2407-9-153.

Additional files

Editorial Notes