CompletedPhase 3

Study to Assess the Safety and Efficacy of Midostaurin (PKC412) in Combination With Standard Chemotherapy During Induction and Consolidation Followed by 12 Months of Maintenance Monotherapy in Patients With Newly-diagnosed FMS-like Tyrosine 3 (FLT3) Kinase Receptor-mutated Acute Myeloid Leukemia.

Bulgaria, Croatia301 participantsStarted 2018-02-13

Plain-language summary

The purpose of this study was to gather and evaluate additional safety and efficacy data on the combination of midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who were eligible for standard induction and consolidation

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Written informed consent must be obtained prior to any screening procedures.
✓. Patients must be 18 years of age or older at the time of signing informed consent.
✓. Patients must have a documented unequivocal diagnosis of AML according to WHO 2008 classification. A bone marrow or blood blast count of ≥ 20% is required, except for AML with t(15;17), t(8;21), inv(16) or t(16;16) where blast count may be \<20%, and, excluding M3 (acute promyelocytic leukemia).
✓. Patients with secondary AML are eligible, e.g. patients with antecedent history of treatment for prior malignancy. AML patients with a history of antecedent treatment for myelodysplasia (MDS), e.g. azacitidine or decitabine, remain eligible for treatment on this study. These agents must have been discontinued for a period of at least 30 days or 5 half-lives of the drug (whichever is greater) before midostaurin can be administered.
✓. Patients must have started "7+3" or "5+2" first induction chemotherapy regimen.
✓. Patients must have a documented FLT3 mutation (ITD or TKD).).
✓. Patients must have an ECOG Performance Status of ≤ 2
✓. Patients requiring intrathecal chemotherapy must have a minimum washout of 48 hours prior to the first dose of midostaurin

Exclusion criteria

✕. Prior therapy for AML with the following exceptions:
✕. emergency leukapheresis

What they're measuring

Percentage of Patients With Adverse Events (AEs), Grade 3 & 4 AEs, Serious Adverse Events (SAEs), AEs Leading to Discontinuation, and Deaths up to 24 Months (M24).

Timeframe: Baseline up to approximatly 24 months

Trial details

NCT IDNCT03379727

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-09

Results submitted2022-07-08

View on ClinicalTrials.gov More Acute Myeloid Leukemia trials