Clinical Trial

Venetoclax in Association With 3+7 and Midostaurin in FLT3-mutated Acute Myeloid Leukemia

Study acronym: MIDOVEN
Not Yet Recruiting Phase 1/2
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Summary
Acute myeloid leukemia (AML) with FLT3 mutation accounts for 30% of patients and is associated with a poor prognosis. Because of the FLT3 mutation, a tyrosine kinase inhibitor, midostaurin (MIDO), is added to the standard treatment with daunorubicin and cytarabine, from D8 to D21 of induction and of each consolidation cycle, followed by one year of maintenance. Venetoclax (VEN), a BCL2 inhibitor, has revolutionized the management of AML patients ineligible for intensive chemotherapy, in combination with azacitidine or cytarabine. The investigators hypothesize that a four-drug induction regimen (daunorubicin+cytarabine+MIDO+VEN) will increase complete remission (CR) rate without measurable residual disease (MRD) and improve event free survival (EFS), relapse free survival (RFS) and overall survival (OS) of this subgroup of patients with unmet medical need.
Trial Details
NCT Number NCT07726576
Lead Sponsor University Hospital, Bordeaux
Conditions Leukemia, Myeloid, Acute
Enrollment 41 participants
Start Date 2026-09
Primary Completion 2027-09 (estimated)
Study Completion 2031-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-24