Dettagli per singolo studio

DEC-NET Serial number IT331

Published online	29/10/2004 10.27.00
Last updated	20/01/2005 11.31.52

Other protocol ID number
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	ACT LYM LEUK W/O RMSION
Experimental drug
prednisone Treatment regimen (dosage and duration) N/A
Dexamethasone Treatment regimen (dosage and duration) N/A
Vincristine Treatment regimen (dosage and duration) N/A
METHOTREXATE Treatment regimen (dosage and duration) N/A
Folinic acid Treatment regimen (dosage and duration) N/A
L-Asparaginasi Treatment regimen (dosage and duration) N/A
Citarabine Treatment regimen (dosage and duration) N/A
mercaptopurine Treatment regimen (dosage and duration) N/A
Tioguanine Treatment regimen (dosage and duration) N/A
Vindesine Treatment regimen (dosage and duration) N/A
Daunorubicin Treatment regimen (dosage and duration) N/A
Ifosfamide Treatment regimen (dosage and duration) N/A
Idarubicin Treatment regimen (dosage and duration) N/A
Cyclophosphamide Treatment regimen (dosage and duration) N/A
G-CSF (Filgrastim) Treatment regimen (dosage and duration) N/A
Etoposide Treatment regimen (dosage and duration) N/A
Fludarabine Treatment regimen (dosage and duration) N/A
Teniposide Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	0-15 years
Eligibility criteria
Inclusion criteria
Relapse of acute lymphoblastic leukaemia


Trial design/methodology
Phase	3
Kind of study	Efficacy Safety
Design	Controlled Randomised
Purpose of study
For S1 patients (tardive em (extramedullary) relapse) .Evaluation of the MRM (minimal residual disease) at the medullary level, in cases of isolated extramedullary relapse, at the start of disease and after induction therapy; .Evaluation of the role of the bone marrow transplant from MFD (Matched family donor) in CNS extramedullary relapses; .Evaluation of the role of the autologous bone marrow transplant in CNS extramedullary relapses without compatible familial donor. For S2 patients (precocious extramedullary relapses; very precocious extramedullary relapses; tardive non-t bone marrow relapses; combined precocious/tardive non-t relapses) .Comparative evaluation, through study of the MRM, of the response to induction therapy in patients treated with chemiotherapy blocks (F1 and F2) versus continual therapy (Phase IA). .Evaluation of the prognostic meaning on the outcome of MRM, assessed at the end of induction therapy; .Evaluation of the therapeutic impact of the bone marrow transplant from MUD (matched unrelated donor) through a retrospective comparison with the AEIOP experience and a meta-analytic one with the BFM (Berlin-Frankfurt-Munster) and UKALL groups. .Evaluation of the therapeutic impact of chemiotherapic intensification and haploidentical bone marrow transplant in patients who are MRM positive ≥ 5 x 10-4 to point 3; .Comparative evaluation, through MRM, of the therapeutic impact of Protocol II versus 3 chemiotherapy blocks (R1, R2, R1) in patients with MRM ≥ 5 x 10-4 after the induction phase. For S3-4 patients (S3: precocious non-t bone marrow relapses, S4: very precocious bone marrow relapses; combined very precocious relapses, bone marrow-t relapses) .Evaluation of the therapeutic efficacy and of the tollerability of the IDA . Ara-C at high doses scheme, versus the FLAG block and Dunoxome; .Evaluation, through study of the MRM, of the efficacy of the FLAG scheme and of the protocol II as consolidation therapy. .Evaluation of the EFS (event-free survival) reached in these patients compared to the AIEOP REC 98 study (retrospective comparison) and to the ongoing BFM and UKALL (meta-analysis) study. For S1-2-3-4 patients who will undergo transplant procedure .Evaluation of the prognostic meaning of the quality of complete remission in the bone marrow sample that precedes the start of the conditioning regimen, assessed through MRM.




Summary of study design, objectives, and ongoing research findings
This protocol aims to uniform the AEIOP.S group chemiotherapy treatments and the indications for translplant for ALL relapses and to contribute to the development of a therapeutic strategy that is common at the European level.