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Terms & conditions
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DUPLICATION
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Your search result may contain a number of different records for the same trial.
This occurs when the same trial is listed in more than one register.
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| Phase III Trial comparing CHOP to PmitCEBO in Good Risk patients with Histologically Aggressive Non-Hodgkin's Lymphoma. |
| Source of record | UK Co-ordinating Committee on Cancer Research (UKCCCR) |
| ISRCTN | ISRCTN23628366 |
| Serial number at source | GOOD RISK |
| Title of trial | Phase III Trial comparing CHOP to PmitCEBO in Good Risk patients with Histologically Aggressive Non-Hodgkin's Lymphoma. |
| Disease or condition | Lymphoma (non-Hodgkin's) |
| Current status of trial | Open |
| Objectives | 1. To compare the efficacy of PmitCEBO and CHOP in younger patients with good prognosis, histologically aggressive NHL in an open randomised trial using the study endpoint of overall survival between the groups randomised to PmitCEBO and CHOP.
2. Failure free survival, disease specific survival, relapse free survival, death due to toxicity, response rate and early and late toxicity. |
| Eligibility 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 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
LDH>upper limit of normal
Performance status 2-4 (ECOG-WHO)
Adequate bone marrow function, indicated by
Haemoglobin > or = 10g/dL
Neutrophils > or = 2 x 10(9)/L
Platelets > or + 100 x 10(9)/L
7. Written informed consent |
| Sample size | Current accrual: 108 |
| Randomised interventions | CHOP regimen:
Chemotherapy with cyclophosphamide, doxorubicin, vincristine and prednisolone repeated every 21 days for 6-8 cycles.
PmitCEBO regimen:
Chemotherapy with mitoxantrone, cyclophosphamide, etoposide, bleomycin, vincristine and prednisolone. Repeated every 14 days for 4-8 cycles. |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
LONDON NW1 2DA
Tel: +44 (0) 20 7670 4723
Fax: +44 (0) 20 7670 4818
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| Further information | Further information about this trial may be obtained from UKCCCR Register's own website, which contains full trial reports. |
| General information | Please visit the UKCCCR Register website for further general information. |
| Date live in mRCT | 01 April 2007 |
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