OncoMatch/Clinical Trials/NCT02416388
Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR
Is NCT02416388 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments for acute myeloid leukemia (aml).
Treatment: Idarubicin · Daunorubicin · HD Cytarabine · Cyclosporine · Methotrexate · Mycophenolic acid (MPA) · vosaroxin · ID cytarabine · Dexamethasone · Venetoclax — This open label, multicenter phase II/III study with multiple randomization phases at differents stages of AML treatment (induction, consolidation and HSCT where applicable) is designed to improve OS in younger (18 to 60 year-old) patients, with AML risk-adapted patient strategies. Within the intermediate risk AML group, optimal GvHD prophylaxis following allogeneic SCT in first CR, after either myeloablative (MAC) or reduced intensity (RIC) conditioning, will also be evaluated. With an adaptative design, this clinical trial could test up to 3 novel AML agents of interest.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: FLT3 ITD
Genetic mutation testing of the FLT3 (FLT3-ITD ou FLT3-TKD) gene, performed in local or central laboratory
Required: FLT3 TKD
Genetic mutation testing of the FLT3 (FLT3-ITD ou FLT3-TKD) gene, performed in local or central laboratory
Excluded: PML RARA fusion
Patients with acute promyelocytic leukemia (APL), as confirmed either by t(15;17) or by the presence of PML-RARA fusion transcripts
Excluded: RUNX1 RUNX1T1 fusion
Patients with core binding factor (CBF) AML, as confirmed either by t(8;21)... or by fusion transcripts resulting from these cytogenetic abnormalities (RUNX1-RUNX1T1, CBFB-MYH11)
Excluded: CBFB MYH11 fusion
Patients with core binding factor (CBF) AML, as confirmed either by t(16,16) or inv(16), or by fusion transcripts resulting from these cytogenetic abnormalities (RUNX1-RUNX1T1, CBFB-MYH11)
Excluded: BCR ABL1 fusion
Patients with Ph1+ AML or previous Ph1+ disorder (chronic myelogenous leukemia)
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Cannot have received: any AML therapy
Exception: hydroxyurea allowed
No prior treatment for neither AML (with the exception of hydroxyurea)
Cannot have received: any MDS therapy
Exception: EPO allowed
no prior treatment for...MDS (with the exception of EPO)
Lab requirements
Kidney function
creatinine < 150 µmol/l, unless AML-related out of range values
Liver function
Total bilirubin ≤ 2 x upper limit of normal (UNL), ASAT(SGOT) and ALAT (SGPT) ≤ 2.5 X UNL
Cardiac function
No cardiac contraindications for the use of anthracyclines: decompensated or uncontrolled heart failure, recent myocardial infarction, current signs of cardiac impairment, uncontrolled arrhythmias, LVEF < 50%
Total bilirubin ≤ 2 x upper limit of normal (UNL), ASAT(SGOT) and ALAT (SGPT) ≤ 2.5 X UNL, creatinine < 150 µmol/l, unless AML-related out of range values; No cardiac contraindications for the use of anthracyclines: decompensated or uncontrolled heart failure, recent myocardial infarction, current signs of cardiac impairment, uncontrolled arrhythmias, LVEF < 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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