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Treatment for Acute Myeloid Leukemia with FLT3 Mutations

A Phase 3, Prospective, Randomized Multi-center Intervention Trial of Early Intensification in AML Patients Bearing FLT3 Mutations Based on Peripheral Blast Clearance: A MYNERVA-GIMEMA Study

Phase 3 Interventional Gruppo Italiano Malattie EMatologiche dell'Adulto · NCT04174612

This study is testing a new treatment plan using a combination of medications for people with newly diagnosed acute myeloid leukemia who have specific genetic mutations.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment172 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto Academic / other
Drugs / interventionschemotherapy
Locations20 sites (Bari and 19 other locations)
Trial IDNCT04174612 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, multi-center, interventional, randomized, open trial aimed at treating patients with acute myeloid leukemia (AML) who have FLT3 mutations. The treatment approach is customized based on the prognostic parameter of peripheral blast clearance (PBC). Participants will receive a combination of Cytarabine, Daunorubicin, and Midostaurin, along with high-dose Cytarabine. The study focuses on newly diagnosed, untreated patients to evaluate the effectiveness of this tailored treatment strategy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with newly diagnosed, untreated acute myeloid leukemia and confirmed FLT3 mutations.

Not a fit: Patients with acute promyelocytic leukemia or specific genetic abnormalities such as t(8;21) or inversion of chromosome 16 will not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could lead to more effective treatment options for patients with FLT3-mutated AML.

How similar studies have performed: Other studies have shown promise in treating FLT3-mutated AML, indicating that this approach is based on previously successful methodologies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patients with de novo AML, untreated, newly diagnosed, according to WHO 2016 criteria
2. Presence of a mutation of FLT3 gene, either ITD and/or TKD
3. Adequate availability of diagnostic biologic material for full cytological, cytogenetic, genetic and immunophenotypic disease characterization according to ELN criteria.
4. Presence of morphologically identifiable blasts on peripheral blood at diagnosis
5. Presence of a Leukemia-associated aberrant immune-phenotype (LAIP) as assessed by MFC (multiparametric flow cytometry) at diagnosis
6. Age between 18 and 65 years, included
7. ECOG performance status 0-2 or disease-related reversible ECOG 3 score following adequate supportive care.
8. Signed written informed consent according to ICH/EU/GCP and national local laws

Exclusion Criteria:

1. Diagnosis of acute promyelocytic leukemia
2. Diagnosis of AML with t(8;21)(q22:q22)/RUNX1-RUNX1T1 and t(16;16)(p13:q22) or inversion of chromosome 16 (16)(p13q22)/CBFB-MYH11; in case of suspicion of CBF-related AML due to morphological and/or immunophenotypic features, specific FISH or molecular testing is strongly recommended in accordance with WHO criteria3,157
3. Patients with LVEF less than 45% (by echocardiogram or MUGA)
4. Pre-existing, uncontrolled pathology such as heart failure (congestive/ischaemic, acute myocardial infarction within the post 3 months, untreatable arrhythmias, NYHA classes III and IV), sever liver disease with total bilirubin ≥2,5 x ULN and/or ALT\>3 ULN (unless attributable to AML), acute or chronic pancreatitis, kidney function impairment with serum creatinine ≥2,5 (unless attributable to AML) and severe neuropsychiatric disorder that impairs the patient's ability to understand and sign the informed consent or to cope with the intended treatment plan. For altered liver, pancreas and kidney function tests, eligibility criteria can be reassessed at 24-96 hours, following the institution of adequate supportive measures.
5. Uncontrolled bacterial or fungal infections
6. QTc \>470 msec on screening ECG (Fridericia's formula)
7. A history of cancer that is not in remission phase following surgery and/or chemotherapy and/or radiotherapy with life expectancy \< 1 year.
8. Pregnancy declared by the patient herself. A pregnancy test is performed at diagnosis and, if applicable, before allogeneic HSCT . Female and male patients who are fertile must agree to use an effective form of contraception with their sexual partners from enrollment through 4 months after the end of treatment.

Where this trial is running

Bari and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Myeloid Leukemia With FLT3/ITD Mutation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.