Adding venetoclax to standard chemotherapy and midostaurin for FLT3 leukemia
Tests adding venetoclax to standard chemotherapy and midostaurin in adults with FLT3-mutated acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Venetoclax in Association With 3+7 and Midostaurin in FLT3-mutated Acute Myeloid Leukemia
Key facts
- Where
- Bayonne, Pessac, and Toulouse, FranceSee the 3 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07726576, who can take part
Where in France
- CH de la côte BasqueBayonne, FranceNo longer taking part
- CHU de Bordeaux Hopital Haut levequePessac, FranceNo longer taking part
- CHU de ToulouseToulouse, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Bordeaux
- Trial code
- NCT07726576
- Record updated
- 24 July 2026
- Original description
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.Read full original descriptionShow less
Phase 1/2 Evaluating the Addition of Venetoclax to Standard 3+7 and Midostaurin Induction Treatment in Patients With FLT3-mutated Acute Myeloid Leukemia Eligible to Intensive Chemotherapy - MIDOVEN
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.
Main inclusion criteria:; Age ≥18 years and ≤70 years; Newly diagnosed AML according to World Health Organization (WHO) 2022 classification; Documented FLT3 gene mutation (-TKD D835 or I836 or -ITD or both) FLT3-ITD is assessed by DNA fragment analysis. Positivity is defined as an ITD/wt ratio of ≥ 0.05 (5%); FLT3-TKD D835 or I836 is assessed by NGS. Positivity is defined as a VAF > 5%; Patient must be eligible for intensive chemotherapy; Main exclusion criteria:; Prior treatment for AML or myelodysplastic (MDS) phase; Prior exposure to VEN or other BCL2 inhibitors; AML secondary to prior hematological disorders, including myelodysplastic syndrome, myeloproliferative disorders and/or therapy-related AML; Acute promyelocytic leukemia, CBF-AML, Phi+ AML; Significant active cardiac disease within 6 months prior to the start of study treatment or QTc interval using Fridericia's formula (QTcF) ≥ 450 msec; Cardiac ejection fraction <45%.