Protocol for treatment and research of acute lymphoblastic leukaemia of childhood of the Dutch childhood oncology group
| ISRCTN | ISRCTN21542083 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21542083 |
| Protocol serial number | SNWLK/DCOG ALL-9 |
| Sponsor | Dutch Childhood Oncology Group (Stichting Kinder Oncologie [SKION]) (The Netherlands) |
| Funders | Dutch governmental grant (The Netherlands), Dutch Health Insurance (The Netherlands) |
- Submission date
- 28/02/2007
- Registration date
- 28/02/2007
- Last edited
- 20/08/2021
- 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 J G de Ridder-Sluiter
Scientific
Scientific
Dutch Childhood Oncology Group (Stichting Kinder Oncologie [SKION])
Leyweg 299
Den Haag
2545 CJ
Netherlands
| Phone | +31 (0)70 367 4545 |
|---|---|
| hderidder@skion.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, non-randomised, non-controlled, clinical trial |
| Secondary study design | Multi-centre |
| Scientific title | Protocol for treatment and research of acute lymphoblastic leukaemia of childhood of the Dutch childhood oncology group |
| Study objectives | The dutch ALL-6 protocol (1984 - 1988) for standard risk childhood Acute Lymphoblastic Leukaemia (ALL) was one of the first to use dexamethasone as a steroid instead of prednisone. This led to surprisingly good results. The ALL-9 protocol thus was meant to reproduce these results and to extend the use to patients with high risk ALL. This reduced intensity protocol is instituted to: 1. Confirm the data obtained in the SNWLK-ALL-6 protocol for standard risk patients 2. Offer significant improvement of cure rate in high risk patients, comparable to international childhood ALL protocols 3. Offer the possibility to conduct window studies with monotherapy 4. Validate the prognostic significance of in vitro drug resistance testing 5. Standardise the minimal residual disease test 6. Evaluate the side effects, especially osteonecrosis and psychological effects of dexamethasone |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Acute Lymphoblastic Leukaemia (ALL) |
| Intervention | Stratification into standard risk and high risk. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Dexamethasone |
| Primary outcome measure(s) |
Survival |
| Key secondary outcome measure(s) |
Event free survival |
| Completion date | 30/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 918 |
| Key inclusion criteria | All children with acute lymphoblastic leukaemia from one year (365 days) until 18 years of age, excluding mature B-cell ALL. |
| Key exclusion criteria | 1. Mature B-cell ALL 2. Relapsed ALL 3. Secondary ALL 4. Pretreatment with corticosteroids or cytostatic drugs in the four weeks preceding diagnosis 5. Patient of whom essential diagnostic tests are missing 6. Patients in whom essential parts of therapy were not given |
| Date of first enrolment | 01/01/1997 |
| Date of final enrolment | 30/10/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Dutch Childhood Oncology Group (Stichting Kinder Oncologie [SKION])
Den Haag
2545 CJ
Netherlands
2545 CJ
Netherlands
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? |
|---|---|---|---|---|---|
| Results article | 01/10/2009 | 20/08/2021 | Yes | No |
Editorial Notes
20/08/2021: Publication reference added.
