Treatment of mature B-cell lymphoma/leukaemia
| ISRCTN | ISRCTN17584197 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17584197 |
| ClinicalTrials.gov (NCT) | NCT00162656 |
| Protocol serial number | NHL9603 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funders | Cancer Research UK, United Kingdom Children's Cancer Study Group (UKCCSG) |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 25/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
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 | Randomized international FAB/LMB96 trial for intermediate risk B-cell non-Hodgkin lymphoma in children and adolescents: it is possible to reduce treatment for the early responding patients. |
| 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-Hodgkins), leukaemia (acute) |
| Intervention | 1. Arm A: A single course of cyclophosphamide, vincristine, prednisolone (COP) followed by two courses of chemotherapy with cyclophosphamide, vincristine, prednisolone, adriamycin, hydrocortisone and methotrexate (COPADM). Patients then receive two courses of etoposide alternating with a single dose of methotrexate. This is followed by four courses of maintenance therapy. 2. Arm B: A single course of COP followed by two courses of COPADM. Patients then receive two courses of reduced dose etoposide alternating with a single dose of methotrexate. This is followed by a single course of maintenance therapy. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cyclophosphamide, vincristine, prednisolone (COP) Cyclophosphamide, vincristine, prednisolone, adriamycin, hydrocortisone and methotrexate (COPADM). |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 15/06/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 18 Years |
| Sex | |
| Key inclusion criteria | 1. B-large cell, small non-cleaved non-Hodgkin's disease or B-cell leukaemia 2. Stages I-IV 3. Aged over 6 months and under 18 years 4. No previous chemotherapy. Emergency radiotherapy or immunotherapy is permitted 5. No congenital immunodeficiency 6. No prior organ transplantation 7. No previous malignancy of any type 8. No medical contraindications to protocol treatments 9. Patients available for a minimal follow-up of 36 months |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1997 |
| Date of final enrolment | 15/06/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
- France
- United States of America
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 | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2007 | 25/01/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/01/2019: Publication reference added
