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 |
| Protocol serial number | 767 |
| Sponsor | Lymphoma Research Trust (UK) |
| Funder | Lymphoma Research Trust (UK) |
- 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
Contact information
Mr Simon Menezes
Scientific
Scientific
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom
| s.menezes@ctc.ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Study acronym | BNLI 60+ |
| Study objectives | 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(s) | Approved by the Human Research Ethics Committees of all participating centres (ref: 98/2/52) |
| Health condition(s) or problem(s) studied | 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 / 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 measure(s) | Failure free survival |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 20/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 880 |
| Key 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 |
| Key exclusion criteria | Patients with lymphoblastic and Burkitt's lymphoma |
| Date of first enrolment | 01/12/1996 |
| Date of final enrolment | 20/04/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom
W1T 4TJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/05/2009 | Yes | No | |
| Plain English results | No | Yes |
Editorial Notes
22/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
