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)
NCT03512197Phase 3Completed
- Lead sponsor
- Novartis Pharmaceuticals (Industry)
- Enrollment
- 511 (actual)
- Start date
- 20 Jul 2018
- Primary completion
- 12 Feb 2021 (actual)
- Study completion
- 12 Feb 2021
- Last update posted
- 21 Aug 2023
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Quadruple
- Arms
- 2
Interventions
- Midostaurin Drug
- Placebo Drug
- Chemotherapy Drug
Conditions and primary outcome
- Acute Myeloid Leukemia (AML)
Primary outcome
Event Free Survival (EFS) (From date of Randomization up to approx. 30 months)
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT03512197 (opens in a new tab)· Licence: public-domain
First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25
Primary outcomes with a statistical analysis
Event Free Survival (EFS)
- Time frame
- From date of Randomization up to approx. 30 months
- Measure
- Median
- Unit
- Months
Midostaurin + Chemotherapy vs Placebo + ChemotherapySuperiority
- Estimate
- 1.0239Hazard Ratio (HR)
- 95% CI, two-sided
- 0.8 to 1.31
- p-value
- Not given
- Method
- Not given
Serious adverse events
Time frame: AEs were reported from 1st dose of study treatment until end of treatment plus 30 days, up to a maximum (max.) duration of 573 days (543 days max. exposure plus 30 days post-treatment) for midostaurin and up to a max. duration of 416 days (386 days max. exp. plus 30 days post-treatment) for placebo. Deaths - collected in the post-treatment survival follow-up period from 31 days after last dose of study medication until the end of the study, up to approx. 18 months. These are not considered AEs.
| Group | Affected | At risk |
|---|---|---|
| Midostaurin + Chemotherapy (On-treatment) | 95 | 245 |
| Placebo + Chemotherapy (On-treatment) | 114 | 249 |
| Midostaurin + Chemotherapy (Post-treatment Survival Follow-up) | 0 | 0 |
| Placebo + Chemotherapy (Post-treatment Survival Follow-up) | 0 | 0 |
Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
1 on PubMedPharmacogenomic, pharmacokinetic, and safety analysis of CYP3A4/CYP3A5 polymorphisms of midostaurin in patients with acute myeloid leukemia.
European journal of clinical pharmacology · 2025 Dec 23
PubMed 41432755 (opens in a new tab)DOI 10.1007/s00228-025-03971-y (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT03512197 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Nothing on this page is medical or investment advice.