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 |
| Protocol serial number | SNLG NHLV(A) |
| Sponsor | Scotland & Newcastle Lymphoma Group (UK) |
| Funder | Scotland & Newcastle Lymphoma Group (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
