Dettagli per singolo studio

DEC-NET Serial number FR348

Published online	03/02/2005 12.00.00
Last updated	07/12/2006 16.14.00

Other protocol ID number	P000305
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	LYMPHOID LEUKEMIA ACUTE
Experimental drug
daunorubicin Treatment regimen (dosage and duration) Intravenous administration at D22 et D29, at the dose of 40 mg/m2 per injection
Gender	Both
Age (range)	> 1 year et < 10 years
Eligibility criteria
Inclusion criteria
-Children with Standard-Risk B-precursor ALL according to the American National Cancer Institute. -Leucocytosis < 50.000/mm3 -Absence of central nervous system lesion. -Absence of t(9; 22), of t(4; 11) or hypoploïd < 44 chromosomes -Absence of transcribed fusion BCR-ABL or MLL-AF4 -Absence of rearrangement of MLL gene detected by FISH or Southern blot in the event of ALL with zero or low expression of the CD10.
Exclusion criteria
- LAL of Burkitt (standard FAB L3) - Presence of one of the following criteria of gravity (only one criterion is sufficient): . Presence of central nervous system involvement . Presence of t(9;22), t(4;11) or a hypoploïdie < 44 chromosomes . Presence of transcribed fusion BCR-ABL or MLL-AF4. . LAL with absence of expression or weak expression of the CD10 and presence of a rearrangement of MLL gene detected by FISH or Southern blot. - Trisomy 21 - Corticothérapy for longer than 8 days before treatment - Children with a past-history of chronic disease not allowing to enter the protocol - Children who could not be followed
Trial design/methodology
Phase	3
Kind of study	Efficacy Safety
Design	Controlled Randomised
Purpose of study
To evaluate the benefit, in term of event free survival, of the administration of anthracyclines during the induction treatment of standard -risk acute lymphoblastic leukemia responders at day 21 (A1 group). Secondary objectives: -To evaluate the impact of anthracyclines on the incidence of high level of residual disease at the end of induction phase(A1 Group). -To evaluate the impact of increasing treatment in chemoresistant patients at d21 or d35-d42 (groups A2 and A3). -To compare the cardiotoxicity in 2 sub-groups of children treated or not with anthracyclines during the induction phase (A1 group). -To analyze treatment relared toxicity.




Summary of study design, objectives, and ongoing research findings
FRALLE 2000-A is undertaken in children with acute lymphoblastic type B leukemia of standard -risk The initial sensitivity to treatment is evaluated by the chemosensitivity at D21 and by the medullary residual disease at D35-D42. Three groups are defined according to the chemorésistance at D21. 1/ A1 group : good responders at D21 are randomized for the administration of anthracyclines. In the absence of high residual disease at D35-D42, they will remain in this group. If the residual disease is high they will be included in group A3. 2/A2 group, chemoresistant patients receive anthracyclines and consolidation identical to that of the A1 group. They are included either in the A1 group if they do not have a raised residual disease at J35-J42, or with the A3 group if residual disease is low at D35-D42. 3/A3 group: patients poor responders at DJ21 and patients of groups A1 or A2 with high residual disease at D35-D42. These patients receive anthracyclines then an intensified treatment. Rate of event free survival will be evaluated at the end of the trial.