NCT07726576Not yet recruitingPhase 1/2
Venetoclax in Association With 3+7 and Midostaurin in FLT3-mutated Acute Myeloid Leukemia
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
Source: ClinicalTrials.gov · Last updated 24 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 41 (estimated)
- First submitted
- 29 May 2026
- Start date
- Sept 2026
- Primary completion date
- Sept 2027
- Lead sponsor
- University Hospital, Bordeaux
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07726576
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 41
- From Sept 2026 to the primary completion date, Sept 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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%
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CH de la côte Basque Coordinator of this site? Confirm its status | Bayonne | France | Unknown status |
| CHU de Bordeaux Hopital Haut leveque Coordinator of this site? Confirm its status | Pessac | France | Unknown status |
| CHU de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.