EICHORCondition: Leukemia, Myeloid, Acute · Sponsor: University Hospital, Bordeaux
Interested? Contact the study team ↓
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
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.
This description comes directly from the study's public registry record.
Pierre-Yves DUMAS, PU-PH · +33 5 57 65 65 11 · pierre-yves.dumas@chubordeaux.fr
Sarah BERTOLI · +33 5 31 15 62 69 · bertoli.sarah@iuct-oncopole.fr
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
Main inclusion criteria: 1. Age ≥18 years and ≤70 years 2. Newly diagnosed AML according to World Health Organization (WHO) 2022 classification 3. 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%. 4. Patient must be eligible for intensive chemotherapy. Main exclusion criteria: 1. Prior treatment for AML or myelodysplastic (MDS) phase. 2. Prior exposure to VEN or other BCL2 inhibitors 3. AML secondary to prior hematological disorders, including myelodysplastic syndrome, myeloproliferative disorders and/or therapy-related AML. 4. Acute promyelocytic leukemia, CBF-AML, Phi+ AML 5. Significant active cardiac disease within 6 months prior to the start of study treatment or QTc interval using Fridericia's formula (QTcF) ≥ 450 msec. 6. Cardiac ejection fraction \<45%
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| CH de la Côte Basque | Bayonne, France | — |
| CHU de Bordeaux - Hôpital haut-Lévêque | Pessac, France | — |
| CHU de Toulouse | Toulouse, France | — |
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07726576