# 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.

> **NCT03379727** · PHASE3 · COMPLETED · sponsor: **Novartis Pharmaceuticals** · enrollment: 301 (actual)

## Conditions studied

- Acute Myeloid Leukemia

## Interventions

- **DRUG:** Midostaurin
- **DRUG:** Cytarabine
- **DRUG:** anthracycline ((daunorubicin or idarubicin): Induction Phase only

## Key facts

- **NCT ID:** NCT03379727
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2018-02-13
- **Primary completion:** 2021-07-09
- **Final completion:** 2021-07-09
- **Target enrollment:** 301 (ACTUAL)
- **Last updated:** 2024-02-29


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03379727

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03379727, "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.". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT03379727. Licensed CC0.

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