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
| ISRCTN | ISRCTN42558989 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42558989 |
| Secondary identifying numbers | SNLG NHLV(A) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 08/11/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
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 |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| 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 | 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 |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1995 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1995 |
| 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
Scotland & Newcastle Lymphoma Group (UK)
Research organisation
Research organisation
Medical Statistics Unit, Department of Public Health Sciences
University of Edinburgh
Medical School
Teviot Place
Edinburgh
EH8 9AG
United Kingdom
Funders
Funder type
Research organisation
Scotland & Newcastle Lymphoma Group (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
