| Source of record | UK Trials |
| ISRCTN | ISRCTN23628366 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | GOOD RISK |
| Public title | Phase III Trial comparing CHOP to PmitCEBO in Good Risk patients with Histologically Aggressive Non-Hodgkin's Lymphoma |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Lymphoma (non-Hodgkin's) |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 10/12/1998 |
| Anticipated end date | 31/12/2004 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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 |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | British National Lymphoma Investigation |
| Sponsor name | British National Lymphoma Investigation (BNLI) |
| Sponsor details | CRC and UCL Cancer Trials Centre
222 Euston Road
London
United Kingdom
NW1 2DA |
| Sponsor telephone | +44(0)20 7679 8060 |
| Sponsor fax | +44(0)20 7679 8061 |
| Sponsor email | bnli@ctc.ucl.ac.uk |
| Sponsor website | http://www.bnli.ucl.ac.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN23628366 |
| Date last extracted from ISRCTN register | 17/04/2008 |
