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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT04385290 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require RUNX1?
Yes, RUNX1 RUNX1-RUNX1T1 is a required biomarker for enrollment.
Does this trial require CBFB?
Yes, CBFB CBFB-MYH11 is a required biomarker for enrollment.
Does this trial require FLT3?
Yes, FLT3 ITD is a required biomarker for enrollment.
Are patients with RUNX1 alterations eligible?
No. RUNX1 RUNX1-RUNX1T1 is an exclusion criterion.
Are patients with CBFB alterations eligible?
No. CBFB CBFB-MYH11 is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages