International protocol for the treatment of childhood anaplastic large cell lymphoma (ALCL)
| ISRCTN | ISRCTN98249374 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98249374 |
| ClinicalTrials.gov (NCT) | NCT00006455 |
| Protocol serial number | NHL 2000/06 |
| 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
- 19/10/2018
- 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 Denise Williams
Scientific
Scientific
Cambridge University Hospitals NHS Foundation Trust
Children's Service
Box No 181
Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 216 878 |
|---|---|
| denise.williams@addenbrookes.nhs |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | International protocol for the treatment of childhood anaplastic large cell lymphoma (ALCL) |
| 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 | Four arms: Arm one: MTX (1 g/m2) over 24 hours with intrathecal Arm two: MTX (1 g/m2) over 24 hours with intrathecal and Vinblastine for one year Arm three: MTX (3 g/m2) over three hours without intrathecal Arm four: MTX (3 g/m2) over three hours without intrathecal and Vinblastine for one year |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | MTX, vinblastine |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 22 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. ALCL diagnosed by local pathologist 2. Slides available for national review 3. Aged <22 years 4. No previous treatment 5. Appropriate ethical approval |
| Key exclusion criteria | Not applicable |
| Date of first enrolment | 01/04/2000 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Cambridge University Hospitals NHS Foundation Trust
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
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 | 01/09/2010 | Yes | No | |
| Results article | results | 26/05/2011 | Yes | No | |
| Results article | results | 01/07/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes |
Editorial Notes
19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
