Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Mr Simon Menezes
ORCID ID
Contact details
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom
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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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19450285
Publication citations
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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.