Phase II Multicentric Trial Maintenance Therapy With 6 Monthly Revlimid® Cycles Alternated With 6 Monthly Vidaza® Cycles in First CR After Induction LIA Chemotherapy for Elderly (≥ 60) Fit Patients With Poor Prognosis Acute Myeloid Leukemia.
- The primary objective of this study will be to improve the DFS with an alternate schema
combining azacitidine and lenalidomide in elderly fit patients with previously
untreated AML and with high risk cytogenetics or secondary AML, who achieved either a
complete remission after an LIA induction therapy
- The secondary objectives will be to determine the relapse incidence, overall survival,
event free survival at 1 and 2 years of follow-up, toxicities of the treatment,
incidence of infectious events.
- To define a gene expression and promoter methylation signatures associated with CR and
absence of relapse when patients received azacitidine and lenalidomide. Gene promoter
methylation and gene expression profiling will be performed at diagnosis, at CR, and
after 2 courses of azacitidine and lenalidomide in order to give insight within the
mechanisms involved by the use of these 2 drugs and to identify new epigenetic
prognostic markers.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
DFS
The primary objective of this study will be to improve the DFS with an alternate schema combining azacitidine and lenalidomide in elderly fit patients with previously untreated AML and with high risk cytogenetics or secondary AML, who achieved either a complete remission after an LIA induction therapy.
18 months
No
Mathilde HUNAULT BERGER, MD PD
Principal Investigator
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
LAMSA-maintenance Rev-5Aza
NCT01301820
January 2011
February 2013
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