A Phase II, Open-Label, multicentre, study investigating tolerability and efficacy of Gilteritinib in combination with fludarabine, cytarabine and idarubicin (FLAI) as induction therapy of newly diagnosed non-M3 FLT3-positive acute myeloid leukemia.GIMEMA AML2924

Conditions

newly diagnosed non-M3 FLT3-positive acute myeloid leukemia

Brief summary

Primary end point is the rate of CR after course 1 or course 2 if course 2 is administered (CR + CRi + CRp).

Detailed description

Percentage of MRD negative CR (flow cytometry) after cycle 1, 2, consolidation, End of Treatment and follow-up (centralized analysis)., To Describe duration of MRD negative CR measured as the time from achievement of MRD negative CR to MRD positive test, relapse or death for any cause., To Describe PFS, measured as the time from 1st day of administration of study treatment to progression or death for any cause., To Describe OS, measured as the time from 1st day of administration of study treatment to death for any cause., To Describe the proportion of patients who proceed to HSCT in MRD negative CR., To Describe the incidence of AE., To Analyze incidence and type of whole gene FLT3 mutations., To Analyze the overlap between conventional MRD and MRD with next generation technologies (NGS) for correlative purposes., To Describe adherence to treatment., To Describe quality of life.

Related papers

No related papers found yet.

Interventions

DRUGXospata 40 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Primary end point is the rate of CR after course 1 or course 2 if course 2 is administered (CR + CRi + CRp).	—

Secondary

Measure	Time frame
Percentage of MRD negative CR (flow cytometry) after cycle 1, 2, consolidation, End of Treatment and follow-up (centralized analysis)., To Describe duration of MRD negative CR measured as the time from achievement of MRD negative CR to MRD positive test, relapse or death for any cause., To Describe PFS, measured as the time from 1st day of administration of study treatment to progression or death for any cause., To Describe OS, measured as the time from 1st day of administration of study treatment to death for any cause., To Describe the proportion of patients who proceed to HSCT in MRD negative CR., To Describe the incidence of AE., To Analyze incidence and type of whole gene FLT3 mutations., To Analyze the overlap between conventional MRD and MRD with next generation technologies (NGS) for correlative purposes., To Describe adherence to treatment., To Describe quality of life.	—

Measure

Time frame

Percentage of MRD negative CR (flow cytometry) after cycle 1, 2, consolidation, End of Treatment and follow-up (centralized analysis)., To Describe duration of MRD negative CR measured as the time from achievement of MRD negative CR to MRD positive test, relapse or death for any cause., To Describe PFS, measured as the time from 1st day of administration of study treatment to progression or death for any cause., To Describe OS, measured as the time from 1st day of administration of study treatment to death for any cause., To Describe the proportion of patients who proceed to HSCT in MRD negative CR., To Describe the incidence of AE., To Analyze incidence and type of whole gene FLT3 mutations., To Analyze the overlap between conventional MRD and MRD with next generation technologies (NGS) for correlative purposes., To Describe adherence to treatment., To Describe quality of life.

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Countries

Italy

Outcome results

None listed