Dettagli per singolo studio

DEC-NET Serial number IT324

Published online	08/10/2004 13.13.00
Last updated	27/01/2005 17.18.39

Other protocol ID number
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	Lymphoid leukemia
Gender	Both
Age (range)	>1 to <18 years
Eligibility criteria
Inclusion criteria
All patients with non-b type ALL
Exclusion criteria
- Pre-treatment with antiblastics - Undifferentiated acute leukaemia - ALL arisen as a second malignant neoplasia - Pre-treatment with steroids at a Prednisone dose equivalent to greater than or equal to 1 mg/Kg/die for a period longer than or equal to 14 days within 30 of diagnosis.
Trial design/methodology
Phase	3
Kind of study	Efficacy Safety Diagnostic
Design	Controlled
Purpose of study
The aim is to verify the hypothesis generated by the European study on the minimal residual disease (MRD) carried out by the BFM group (MRD-Berlin-Frankfurt-Muenster) which suggests the possibility of modifying chemiotherapy by reducing or increasing treatment intensity in groups of patients identified no longer only by certain characteristics at diagnosis, but also by an evaluation of the response to induction therapy as measured by molecular methodologies. In the meantime, certain modifications will be made to the therapeutic regimen (for example the introduction of dexamethasone during the induction phase) which deserve a randomised evaluation. In this context, specific projects will be activated, parallel to the 2000 protocol, with the aim to study biological and clinical phenomena associated with specific aspects of the protocol. An evaluation of whether stratifying patients based essentially on the establishment of the MRD will improve the overall prognosis of ALL, obtaining also a more personalised therapy both in terms of a decreased intensity for patients with a better prognosis and of an increased intensity for patients at higher risk of relapse, will be made.