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Protocol for treatment and research of acute lymphoblastic leukaemia of childhood of the Dutch Childhood Oncology Group (SNWLK/DCOG ALL-9).


- candidate number1295
- NTR NumberNTR460
- ISRCTNISRCTN21542083
- Date ISRCTN created28-feb-2007
- date ISRCTN requested18-nov-2005
- Date Registered NTR24-aug-2005
- Secondary IDsN/A 
- Public TitleProtocol for treatment and research of acute lymphoblastic leukaemia of childhood of the Dutch Childhood Oncology Group (SNWLK/DCOG ALL-9).
- Scientific TitleProtocol for treatment and research of acute lymphoblastic leukaemia of childhood of the Dutch Childhood Oncology Group (formerly Stichting Nederlandse Werkgroep Leukemie bij Kinderen, SNWLK).
- ACRONYMSNWLK-ALL-9
- hypothesisThis 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 reststance testing;
5. Standardise the minimal residual disease test;
6. Evaluate the side effects, especially osteonecrosis and psychological effects of dexamethasone.
- Healt Condition(s) or Problem(s) studiedAcute Lymphoblastic Leukemia
- Inclusion criteriaAll children with acute lymphoblastic leukaemia from 1 year (365 days) until 18 years of age, excluding mature B-cell ALL.
- Exclusion criteria1. Mature B-cell ALL;
2. Relapsed ALL;
3. Secondary ALL;
4. Pretreatment with corticostroids or cytostatic drugs in the 4 weeks preceding diagnosis;
5. Patient of whom essential diagnostic tests are missing;
6. Patients in whom essential parts of therapy were not given.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-jan-1997
- planned closingdate30-okt-2004
- Target number of participants918
- InterventionsStratification into standard risk and high risk.
- Primary outcomeSurvival.
- Secondary outcomeEvent free survival.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. J.G. Ridder-Sluiter, de
- CONTACT for SCIENTIFIC QUERIESProf. Dr. A.J.P. Veerman
- Sponsor/Initiator Dutch Childhood Oncology Group
- Funding
(Source(s) of Monetary or Material Support)
Governmental grant, Health Insurance
- PublicationsN/A
- Brief summaryThe dutch ALL-6 protocol (1984-1988) for standard risk childhood ALL was one of the first to use dexamethasone as 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. Presently the probability of 5-year EFS is 80%+/-2%, (for SR patients 83%, for HR patients 70%)overall.
- Main changes (audit trail)
- RECORD24-aug-2005 - 16-jun-2008


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