A Global Study of the Efficacy and Safety of Midostaurin + Chemotherapy in Newly Diagnosed Patients With FLT3 Mutation Negative (FLT3-MN) Acute Myeloid Leukemia (AML)

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Myeloid Leukemia (AML)

In brief

The purpose of this study was to confirm the preliminary evidence from early clinical trials that midostaurin may provide clinical benefit not only to AML patients with the FLT3-mutations but also in FLT3-MN (SR\<0.05) AML (FLT3 mutant to wild type signal ratio below the 0.05 clinical cut-off). This study evaluated the efficacy and safety of midostaurin in combination with daunorubicin or idarubicin and cytarabine for induction and intermediate-dose cytarabine for consolidation, and midostaurin single agent post-consolidation therapy in newly diagnosed patients with FLT3-MN (SR\<0.05) AML.

Key facts

Study ID

NCT03512197

Run by

Novartis Pharmaceuticals

People needed

511

Starts

2018-07-20

Expected to finish

2021-02-12

Last updated by the study team

2023-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of AML (≥20% blasts in the bone marrow based on WHO 2016 classification). Patients with APL with PML-RARA are not eligible.
• Suitability for intensive induction chemotherapy in the judgment of the investigator
• Documented absence of an ITD and TKD activating mutation at codons D835 and I836 in the FLT3 gene, as determined by analysis in a Novartis designated laboratory using a validated clinical trial assay with clinical cutoff of 0.05 mutant to wild type signal ratio
• Age ≥18 years
• Laboratory values that indicate adequate organ function assessed locally at the screening visit

You may not qualify if…

• Central nervous system (CNS) leukemia
• Therapy-related secondary AML
• Isolated extramedullary leukemia
• Prior therapy for leukemia or myelodysplasia
• AML after antecedent myelodysplasia (MDS) with prior cytotoxic treatment (e.g., azacytidine or decitabine)
• Prior treatment with a FLT3 inhibitor (e.g., midostaurin, quizartinib, sorafenib)

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Oregon Health and Science Univ — Portland, Oregon, United States
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — Westmead, New South Wales, Australia
• Novartis Investigative Site — Woolloongabba, Queensland, Australia
• Novartis Investigative Site — Prahran, Victoria, Australia
• Novartis Investigative Site — Murdoch, Western Australia, Australia
• Novartis Investigative Site — Linz, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Antwerp, Belgium
• Novartis Investigative Site — Bruges, Belgium
• Novartis Investigative Site — Roeselare, Belgium
• Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, Brazil
• Novartis Investigative Site — Sofia, Bulgaria
• Novartis Investigative Site — Brno-Bohunice, Czechia
• Novartis Investigative Site — Plzen-Bory, Czechia
• Novartis Investigative Site — Bayonne, Bayonne Cedex, France
• Novartis Investigative Site — Angers, France
• Novartis Investigative Site — Avignon, France
• Novartis Investigative Site — Dijon, France
• Novartis Investigative Site — Lille, France
• University of Chicago Medical Center . — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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