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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 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 511 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03512197
The ClinicalTrials.gov registry entry for NCT03512197 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 511 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03512197 reports 0 study locations.
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.
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