Dettagli per singolo studio

DEC-NET Serial number IT330

Published online	28/10/2004 11.24.00
Last updated	21/07/2005 16.01.42

Other protocol ID number
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	ACT MYL LEUK W/O RMSION
Experimental drug
Cyclophosphamide Treatment regimen (dosage and duration) N/A
Cytarabine Treatment regimen (dosage and duration) N/A
Etoposide Treatment regimen (dosage and duration) N/A
Idarubicin Treatment regimen (dosage and duration) N/A
Melphalan Treatment regimen (dosage and duration) N/A
Mesna Treatment regimen (dosage and duration) N/A
Mitoxantrone Treatment regimen (dosage and duration) N/A
Busulfan Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	0 . 18 years (17 and 364 days) on diagnosis
Eligibility criteria
Inclusion criteria
Patients with AML
Exclusion criteria
Down.s Syndrome FAB M3 with PML-RARα rearrangement (Promyelocytic Leukemia (Protein)- Retinoic Acid Receptor α)) and/or t(15;17) Secondary LAM at Myelodisplasia LAM-t (therapy-related AML) Serious organ dysfunctions
Trial design/methodology
Phase	3
Kind of study	Efficacy Safety
Design	Controlled
Purpose of study
Primary: -Guarantee patients with AML an Event Free Survival after 5 years that is no less than 40%. Secondary: -Make AML therapy in the AIEOP network.s centres uniform. -Evaluate stratification based on: biological-molecular studies and precocious response. -Reduce therapeutic load in 15-20% of patients at standard risk (SR). -Guarantee a molecular and cytogenic evaluation for all cases. -Evaluate the prognostic meaning of the MRMD (Minimal Residual Marrow Disease) Ancillary: -Monitor the cardiac toxicity on the short and long term. -Evaluate the prognostic meaning of the bone marrow (BM) on the 14th day of the I Induction Cycle. -Analyse the FAB (French-American-British classification) subgroups with peculiar clinical characteristics (M0, M6, and M7. -Analyse subgroups with peculiar biological characteristics (CTLp, Flt3-ITD, MLL/AF9).




Summary of study design, objectives, and ongoing research findings
Design: Prospective, multicentre study with historical control. Main objective: Guarantee patients with AML an EFS (event free survival) at 5 years of no less than 40%. Treatment plan: Patients will be stratified into 2 risk categories, standard (SR) and high (HR), based on their response to the first induction treatment cycle and on the presence of isolated cytogenetic anomalies such as the t(8;21) or anomalies in the CBFsub-unit of the Core-Binding Factor). For the SR category no transplant option is planned in I complete remission, but only chemiotherapic treatment: 2 intensive induction cycles (ICE) followed by 3 blocks: AVE, HAM and HD-Ara-C (Ara-C and VEpesid, high-dose Ara-C and mitoxantrone, and high-dose Ara-C). For the HR category the same two intensive induction cycles (ICE) followed by two blocks (AVE and HAM) prior to the transplant procedure: TMOall, in the presence of a familial HLA-compatible donor, or, in alternative, TMOauto with purging, both preceded by a conditioning regime based on the use of the 3 alkilating agents busulfano (BU), cyclophosphamide (CY) and melphalan (L-PAM).