OncoMatch/Clinical Trials/NCT04385290
Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)
Is NCT04385290 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for acute myeloid leukemia.
Treatment: MODULE: conventional chemotherapy (Cytarabine+Daunorubicin) in combination with midostaurin+GO · MAGNOLIA-trial: Midostaurin associated with conventional chemotherapy (AraC+DNR)+GO · MAGNOLIA-trial: conventional chemotherapy (AraC+DNR)+GO · MAGMA-trial:GO associated with conventional chemotherapy (AraC+DNR)+Midostaurin · MAGMA-trial: conventional chemotherapy (AraC+DNR)+Midostaurin — This phase I/II clinical trial evaluates the safety and efficacy of the combined administration of midostaurin and gemtuzumab ozogamicin in the frame of first-line standard chemotherapy in newly diagnosed acute myeloid leukemia (AML) patients displaying a cytogenetic aberration or fusion transcript in the core-binding factor (CBF) genes or FMS-like tyrosine Kinase 3 (FLT3) mutation.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: RUNX1 RUNX1-RUNX1T1
t(8;21)/RUNX1-RUNX1T1
Required: CBFB CBFB-MYH11
inv(16) or t(16;16)/CBFB-MYH11
Required: FLT3 ITD
FLT3-ITD
Required: FLT3 TKD
FLT3-tyrosine kinase domain (FLT3-TKD)
Excluded: RUNX1 RUNX1-RUNX1T1
Absence of mutations in CBF genes (i.e. t(8;21)/RUNX1-RUNX1T1 or inv(16) or t(16;16)/CBFB-MYH11)
Excluded: CBFB CBFB-MYH11
Absence of mutations in CBF genes (i.e. t(8;21)/RUNX1-RUNX1T1 or inv(16) or t(16;16)/CBFB-MYH11)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: antineoplastic treatment for AML
Exception: hydroxyurea and/or cytarabine for emergency use (100-200 mg/m^2 per day on maximal 3 days)
Previous antineoplastic treatment for AML other than hydroxyurea and/or cytarabine for emergency use (100-200 mg/m^2 per day on maximal 3 days)
Cannot have received: anthracycline
Previous treatment with anthracyclines
Cannot have received: cytotoxic treatment for antecedent myelodysplasia (MDS) (azacytidine, decitabine)
AML after antecedent myelodysplasia (MDS) with prior cytotoxic treatment (e.g., azacytidine or decitabine)
Cannot have received: FLT3 inhibitor (midostaurin, quizartinib, sorafenib)
Prior treatment with a FLT3 inhibitor (e.g., midostaurin, quizartinib, sorafenib)
Cannot have received: investigational agent
Any investigational agent within 30 days or 5 half-lives, whichever is greater, prior to day 1
Lab requirements
Blood counts
White blood cell count < 30 × 10^9/L
Kidney function
Creatinine < 1.5 x upper limits of normal or Creatinine clearance > 40 ml/min
Liver function
alanine aminotransferase / aspartate transaminase ≤ 2.5 x ULN; Bilirubin < 2 x upper limits of normal
Cardiac function
Left ventricular ejection fraction of < 50%; no history of myocardial infarction, angina pectoris, Coronary Artery Bypass Grafting within 6 months; no clinically uncontrolled cardiac arrhythmias, complete left bundle branch block, high-grade atrioventricular block, uncontrolled congestive heart failure, poorly controlled arterial hypertension
Adequate hepatic and renal function; White blood cell count < 30 × 10^9/L; Cardiovascular abnormalities, including any of the following: History of myocardial infarction, angina pectoris, Coronary Artery Bypass Grafting within 6 months prior to starting study treatment; Clinically uncontrolled cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular block (e.g., bifascicular block, Mobitz type II and third degree atrioventricular block); Uncontrolled congestive heart failure; Left ventricular ejection fraction of < 50%; Poorly controlled arterial hypertension
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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