Acute Myeloid Leukemia Clinical Trial
Official title:
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 Fit Patients With Poor Prognosis Acute Myeloid Leukemia.
Phase II Multicentric Trial Open Label, Multicenter, randomized to evaluate the efficacy of
a Maintenance Therapy in First Complete Remission After Induction for Elderly (≥ 60) Fit
Patients With Poor Prognosis Acute Myeloid Leukemia (AML).
The disease-free survival (DFS) of the patients included in this study will be compared to
the ones of the two previously reported groups of patients treated with the same LIA
induction therapy
- 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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