Plain English Summary
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
GOOD RISK
Study information
Scientific title
Acronym
Not Applicable
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
Condition
Lymphoma (non-Hodgkin's)
Intervention
1. CHOP regimen: Chemotherapy with cyclophosphamide, doxorubicin, vincristine and prednisolone repeated every 21 days for 6-8 cycles
2. PmitCEBO regimen: Chemotherapy with mitoxantrone, cyclophosphamide, etoposide, bleomycin, vincristine and prednisolone. Repeated every 14 days for 4-8 cycles
Intervention type
Drug
Phase
Not Specified
Drug names
Various
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
10/12/1998
Overall trial end date
31/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Previously untreated non-Hodgkin's Lymphoma of the following types: follicular large cell lymphoma, diffuse mixed cell lymphoma diffuse large cell lymphoma diffuse immunoblastic lymphoma 0r Revised European/American Lymphoma (REAL) classification: diffuse large B peripheral T cell lymphoma
2. Bulky stage IA and stages IB-IV (Ann Arbour staging system)
3. Age 18-59 years
4. Measurable or evaluable disease
5. Good prognosis, defined as the presence of no more than one of the following adverse features: Stage III/IV Lactic dehydrogenase (LDH) >upper limit of normal Performance status 2-4 (Eastern Cooperative Oncology Group [ECOG]-World Health Organisation [WHO]) Adequate bone marrow function, indicated by Haemoglobin ≥10 g/dL Neutrophils ≥2 x 10^9/L Platelets ≥100 x 10^9/L
6. Written informed consent
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
10/12/1998
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
British National Lymphoma Investigation (BNLI) (UK)
Sponsor details
CRC and UCL Cancer Trials Centre
222 Euston Road
London
NW1 2DA
United Kingdom
+44 (0)20 7679 8060
bnli@ctc.ucl.ac.uk
Sponsor type
Charity
Website
Funders
Funder type
Research organisation
Funder name
British National Lymphoma Investigation (BNLI) (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
-
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.