Phase III Trial comparing CHOP to PmitCEBO in Good Risk patients with Histologically Aggressive Non-Hodgkin's Lymphoma
ISRCTN | ISRCTN23628366 |
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DOI | https://doi.org/10.1186/ISRCTN23628366 |
ClinicalTrials.gov number | NCT00005867 |
Secondary identifying numbers | GOOD RISK |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 27/09/2019
- 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
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Phase III Trial comparing CHOP to PmitCEBO in Good Risk patients with Histologically Aggressive Non-Hodgkin's Lymphoma |
Study acronym | Not Applicable |
Study objectives | Not provided at time of registration |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Various |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 10/12/1998 |
Completion date | 31/12/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Senior |
Lower age limit | 18 Years |
Upper age limit | 59 Years |
Sex | Both |
Target number of participants | Not provided at time of registration |
Key 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 |
Key exclusion criteria | Does not meet inclusion criteria |
Date of first enrolment | 10/12/1998 |
Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
British National Lymphoma Investigation (BNLI) (UK)
Charity
Charity
CRC and UCL Cancer Trials Centre
222 Euston Road
London
NW1 2DA
United Kingdom
Phone | +44 (0)20 7679 8060 |
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bnli@ctc.ucl.ac.uk | |
Website | http://www.bnli.ucl.ac.uk |
Funders
Funder type
Research organisation
British National Lymphoma Investigation (BNLI) (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 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 |
Editorial Notes
27/09/2019: ClinicalTrials.gov number added.