No registrations found.
ID
Source
Brief title
Health condition
Acute lymphoblastic leukaemia of childhood.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Survival.
Secondary outcome
Event free survival.
Background summary
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.
Study objective
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.
Study design
N/A
Intervention
Stratification into standard risk and high risk.
Leyweg 299
J.G. Ridder-Sluiter, de
Den Haag 2545 CJ
The Netherlands
+31 (0)70 3674545
hderidder@skion.nl
Leyweg 299
J.G. Ridder-Sluiter, de
Den Haag 2545 CJ
The Netherlands
+31 (0)70 3674545
hderidder@skion.nl
Inclusion criteria
All children with acute lymphoblastic leukaemia from 1 year (365 days) until 18 years of age, excluding mature B-cell ALL.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL420 |
| NTR-old | NTR460 |
| Other | : N/A |
| ISRCTN | ISRCTN21542083 |