| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN42558989 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | SNLG NHLV(A) |
| Public title | A Randomised Study of High-Dose Chemotherapy/ Radiotherapy and Autologous Bone Marrow Transplantation in Patients with High Grade Non-Hodgkin's Lymphoma in First Complete Remission |
| Scientific title |
|
| 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. Patients with high grade non-Hodgkin's lymphoma
2. Stage I-IV disease, stage I and II patients must require chemotherapy
3. Aged 15 to 65 years
4. Adequate marrow, hepatic and renal function
5. Patients with localised gut lymphoma, Burkitt's lymphoma and lymphoblastic T-cell with large mediastinal mass are excluded
6. No central nervous system (CNS) involvement
7. No previous malignant disease except skin or cervical carcinoma stage I |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/1995 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | All patients receive induction chemotherapy with CHOP or VAPEC-B. Patients in complete or good partial remission following induction receive radiotherapy to the areas of bulky disease.
Patients are then randomised as follows:
GOOD RISK PATIENTS: Good risk patients are randomised to one of two treatment arms:
1. Arm A: No treatment
2. Arm B: High dose melphan and autologous bone marrow transplant (ABMT)
INTERMEDIATE/POOR PATIENTS: Patients are randomised to one of two treatment arms:
3. Arm C: High dose melphan and ABMT
4. Arm D: Patients receive high dose melphan, total body irradiation 10.5 Gy in three fractions over 24 h plus ABMT or a BEAM chemotherapy transplant |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Scotland & Newcastle Lymphoma Group |
| Sponsor name | Scotland & Newcastle Lymphoma Group |
| Sponsor details | Medical Statistics Unit, Department of Public Health Sciences
University of Edinburgh
Medical School
Teviot Place
Edinburgh
United Kingdom
EH8 9AG |
| 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 | ISRCTN42558989 |
| Date last extracted from ISRCTN register | 17/04/2008 |
