| Source of record | UK Trials |
| ISRCTN | ISRCTN97344827 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | LY02 |
| Public title | A randomised trial to evaluate early high dose therapy and autologous bone marrow transplantation as part of planned initial therapy for poor risk intermediate/high grade non-Hodgkin's lymphoma |
| Scientific title |
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| Acronym | N/A |
| 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. Age 16-65 years
2. No medical conditions other than lymphoma, prohibiting intensive therapy. No systemic treatment for cancer in the previous 5 years
3. Histology: Follicular large cell lymphoma; Diffuse mixed cell lymphoma; Diffuse large cell lymphoma; Diffuse immunoblastic lymphoma
4. Full clinical staging to include Computed Tomography (CT) scanning of abdomen and bone marrow trephine biopsy
5. Poor prognostic features, defined as the presence of two or three of: Stage III or IV; Lactic dehydrogenase (LDH) > normal; Performance status 2-4 (Eastern Cooperative Oncology Group [ECOG]-World Health Organisation [WHO]) |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
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| Anticipated end date | 31/10/2001 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Following randomisation patients receive standard chemotherapy with cyclophosphamide, hydroxydaunorubicin, vincristine and prednisone (CHOP) to be repeated every 21 days for three courses. Patients who show partial or complete response following initial chemotherapy are treated according to the initial randomisation:
1. Regimen A: Continue standard chemotherapy with (CHOP) to be given for two courses beyond complete remission with a minimum of six courses or until progression.
2. Regimen B: High dose therapy with BCNU, etoposide, cytosine-arabinoside and melphan plus ABMT. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.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 | ISRCTN97344827 |
| Date last extracted from ISRCTN register | 17/04/2008 |
