Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase Ib/II Study Assessing the BET-bromodomain (BRD) Inhibitor OTX015 in Combination With Azacitidine (AZA) or AZA Single Agent in Patients With Newly-diagnosed Acute Myeloid Leukemia (AML) Not Candidate for Standard Intensive Induction Therapy (SIIT)
This study is designed in its first part (phase Ib) to determine the recommended dose of the
OTX015 + Vidaza (azacitidine) combination in newly diagnosed acute myeloid leukemia patients
not candidate for standard intensive induction therapy.
It will be followed by a randomized phase II part to assess the efficacy of the combination
using 2 arms : Vidaza (azacitidine) alone vs. OTX015 in combination with Vidaza
(azacitidine).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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