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.

Phase 3 Completed 301 enrolled Novartis Pharmaceuticals

NaSingle-groupOpen-labelTreatment

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

Timeline

Start: 2018-02-13
Primary completion: 2021-07-09
Completion: 2021-07-09

Publications

Sierra J, Montesinos P, Thomas X, Griskevicius L, Cluzeau T, Caillot D, Legrand O, Minotti C, Luppi M, Farkas F, Bengoudifa BR, Gilotti G, Hodzic S, Rambaldi A, Venditti A. Midostaurin plus daunorubicin or idarubicin for young and older adults with FLT3-mutated AML: a phase 3b trial. Blood Adv. 2023 Nov 14;7(21):6441-6450. doi: 10.1182/bloodadvances.2023009847.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Midostaurin	Small molecule	50 mg	Oral
Background	Cytarabine	Small molecule	100 mg/m2	Intravenous
Background	Cytarabine	Small molecule	200 mg/m2	Intravenous
Background	Cytarabine	Small molecule	1 g	Intravenous
Background	Daunorubicin	Small molecule	60 mg/m2	Intravenous
Background	Daunorubicin	Small molecule	90 mg/m2	Intravenous
Background	Idarubicin	Small molecule	12 mg/m2	Intravenous

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.

Summary

Timeline

Publications

Drugs

Indications