CHOP versus PMItCEBO with/without G-CSF in patients aged sixty years plus with non-hodgkin's lymphoma

ISRCTN ISRCTN98741793
DOI https://doi.org/10.1186/ISRCTN98741793
Secondary identifying numbers 767
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
22/10/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-of-chemotherapy-for-people-over-60-with-aggressive-non-hodgkins-lymphoma

Contact information

Mr Simon Menezes
Scientific

90 Tottenham Court Road
London
W1T 4TJ
United Kingdom

Email s.menezes@ctc.ucl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleA 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
Study acronymBNLI 60+
Study objectives1. 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(s)Approved by the Human Research Ethics Committees of all participating centres (ref: 98/2/52)
Health condition(s) or problem(s) studiedNon-Hodgkin's lymphoma
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Cyclophosphamide, adriamycin, vincristine and prednisolone (CHOP), mitoxantrone, cyclophosphamide, etoposide, bleomycin, vincristine and prednisolone (PMItCEBO), granulocyte colony-stimulating factor (G-CSF)
Primary outcome measureFailure free survival
Secondary outcome measuresNot provided at time of registration
Overall study start date01/12/1996
Completion date20/04/2004

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participantsPlanned sample size: 880
Key inclusion criteria1. 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
Key exclusion criteriaPatients with lymphoblastic and Burkitt's lymphoma
Date of first enrolment01/12/1996
Date of final enrolment20/04/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

90 Tottenham Court Road
London
W1T 4TJ
United Kingdom

Sponsor information

Lymphoma Research Trust (UK)
Charity

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

Website http://www.lymphoma-research-trust.org.uk/
ROR logo "ROR" https://ror.org/01e2zk874

Funders

Funder type

Charity

Lymphoma Research Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Plain English results No Yes
Results article results 18/05/2009 Yes No

Editorial Notes

22/10/2018: Cancer Research UK lay results summary link added to Results (plain English)