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NCT03512197 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 511
- Enrollment target
NCT03512197: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT03512197 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 511 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03512197, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 511 participants
- Enrollment target
Study Summary
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.
Primary Outcome
EFS was defined as the time from randomization to failure to obtain a complete remission (CR) or Complete remission with incomplete hematologic recovery (CRi) with adequate blood count recovery in induction, relapse after CR or CRi with adequate blood count recovery or death due to any cause, whichever occurred first as assessed by the investigator.
Interventions
- DRUG Placebo
- DRUG Chemotherapy
- DRUG Midostaurin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 511 participants |
| Start Date | 2018-07-20 |
| Est. Completion | 2021-02-12 |
| Phase | Phase 3 |
What the finished NCT03512197 record still lists
NCT03512197 is an interventional study that assigns participants to a tested intervention. The registered 511 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03512197 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03512197 about?
NCT03512197 is a clinical study titled "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)". 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). Thi...
What is the current status of trial NCT03512197?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 511 participants. The study started on 2018-07-20. Estimated completion is 2021-02-12.
What interventions are being tested in trial NCT03512197?
The interventions under investigation include: Placebo (DRUG), Chemotherapy (DRUG), Midostaurin (DRUG).
Who is sponsoring clinical trial NCT03512197?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03512197's enrollment target sits among peer trials
511 728th of 2000 higher than 1,272 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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