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…
ID
Bron
Verkorte titel
Aandoening
Acute lymphoblastic leukaemia of childhood.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Survival.
Achtergrond van het onderzoek
The 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.
Doel van het onderzoek
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 reststance testing;
5. Standardise the minimal residual disease test;
6. Evaluate the side effects, especially osteonecrosis and psychological effects of dexamethasone.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Stratification into standard risk and high risk.
Publiek
Leyweg 299
J.G. Ridder-Sluiter, de
Den Haag 2545 CJ
The Netherlands
+31 (0)70 3674545
hderidder@skion.nl
Wetenschappelijk
Leyweg 299
J.G. Ridder-Sluiter, de
Den Haag 2545 CJ
The Netherlands
+31 (0)70 3674545
hderidder@skion.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
All children with acute lymphoblastic leukaemia from 1 year (365 days) until 18 years of age, excluding mature B-cell ALL.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL420 |
| NTR-old | NTR460 |
| Ander register | : N/A |
| ISRCTN | ISRCTN21542083 |