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.
NCT03379727Phase 3Completed
- Lead sponsor
- Novartis Pharmaceuticals (Industry)
- Enrollment
- 301 (actual)
- Start date
- 13 Feb 2018
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 9 Jul 2021
- Last update posted
- 29 Feb 2024
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None
- Arms
- 1
Interventions
- Midostaurin Drug
- Cytarabine Drug
- anthracycline ((daunorubicin or idarubicin): Induction Phase only Drug
Conditions and primary outcome
- Acute Myeloid Leukemia
Primary outcome
Percentage of Patients With Adverse Events (AEs), Grade 3 & 4 AEs, Serious Adverse Events (SAEs), AEs Leading to Discontinuation, and Deaths up to 24 Months (M24). (Baseline up to approximatly 24 months)
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT03379727 (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
No primary outcome with a statistical analysis is posted for this study.
Serious adverse events
Time frame: Adverse Events were reported from first dose of study treatment until end of treatment plus 30 days, up to a maximum duration of 25 months (24 months plus 1 month (30 days) post treatment).
| Group | Affected | At risk |
|---|---|---|
| Induction Phase | 76 | 301 |
| Consolidation Phase | 67 | 210 |
| Maintenance Phaase | 7 | 93 |
| Overall | 137 | 301 |
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 PubMedMidostaurin plus daunorubicin or idarubicin for young and older adults with FLT3-mutated AML: a phase 3b trial.
Blood advances · 2023 Nov 14
PubMed 37581981 (opens in a new tab)DOI 10.1182/bloodadvances.2023009847 (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
- NCT03379727 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.