# 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)

> **NCT03512197** · PHASE3 · COMPLETED · sponsor: **Novartis Pharmaceuticals** · enrollment: 511 (actual)

## Conditions studied

- Acute Myeloid Leukemia (AML)

## Interventions

- **DRUG:** Midostaurin
- **DRUG:** Placebo
- **DRUG:** Chemotherapy

## Key facts

- **NCT ID:** NCT03512197
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2018-07-20
- **Primary completion:** 2021-02-12
- **Final completion:** 2021-02-12
- **Target enrollment:** 511 (ACTUAL)
- **Last updated:** 2023-08-21


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03512197

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03512197, "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)". Retrieved via AI Analytics 2026-07-20 from https://api.ai-analytics.org/clinical/NCT03512197. Licensed CC0.

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