Trial · NCT03379727
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.
NCT03379727, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2024-02-08
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. 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. Trials, record NCT03379727. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03379727
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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.
- NCT number
- NCT03379727
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 301 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Midostaurin, Cytarabine, anthracycline ((daunorubicin or idarubicin): Induction Phase only
- First posted
- 2017-12-20
- Last updated
- 2024-02-29
- Other registries' IDs
- eudract:2016-004440-12
- Results first posted
- 2024-02-08
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Safety of Midostaurin was represented by various types of AEs, SAEs \& death up to M24. AE: the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained. AE grades to characterize the severity of AEs were based on the Common Terminology Criteria for AEs ver. 4.03 with Grade (Gr) 1: mild; Gr 2: moderate; Gr 3: severe; Gr 4: life-threatening; Gr 5: death related to AE. AEs not related to hematological toxicities were generally of grade 1 or 2 severity. SAE: 1 of the following: is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, is medically significant, i.e. an event that jeopardizes the patient or may require medical or surgical intervention to prevent 1 of the outcomes listed above, requires inpatient hospitalization or prolongation of existing hospitalization with a few exceptions. |
| Secondary | Percentage of Patients With Complete Remission (CR) or Complete Remission With Incomplete Hematologic Recovery (CRi) as Per Local Assessment | Baseline up to approximately 24 months | CR/CRi rate is defined as the percentage of patients with complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) as per local assessment in Induction, Consolidation and Maintenance phases. CR/CRi rate was calculated based on the full analysis set (FAS). Complete remission (CR): Bone marrow blasts \<5% with spicules; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) \>1.0 x109/L; platelet count \>100 x 109/L; independence of red cell transfusions. CR with incomplete recovery (CRi): All CR criteria except for residual neutropenia (\<1.0 x109/L) or thrombocytopenia (\<100 x 109/L) |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Safety Set: The safety set comprises all subjects who received at least one dose of midostaurin | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients With Complete Remission (CR) or Complete Remission With Incomplete Hematologic Recovery (CRi) as Per Local Assessment | Baseline up to approximately 24 months | The full analysis set (FAS) comprises all subjects who received at least one dose of midostaurin and have a documented FLT3 mutation (ITD or TKD). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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). | Midostaurin | Adverse events (AEs) - all grades | 295 | Participants | |
| 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). | Midostaurin | Grade >=3 AEs | 254 | Participants | |
| 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). | Midostaurin | Serious adverse events (SAEs) - all grades | 137 | Participants | |
| 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). | Midostaurin | AEs leading to discontinuation - all grades | 40 | Participants | |
| 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). | Midostaurin | Deaths | 19 | Participants | |
| Percentage of Patients With Complete Remission (CR) or Complete Remission With Incomplete Hematologic Recovery (CRi) as Per Local Assessment | Midostaurin | Complete remission (CR) | 196 | Participants | |
| Percentage of Patients With Complete Remission (CR) or Complete Remission With Incomplete Hematologic Recovery (CRi) as Per Local Assessment | Midostaurin | Complete remission with incomplete recovery (CRi) | 46 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Midostaurin | 301 | |
| Overall Study | Entered Induction Phase | Midostaurin | 301 | |
| Overall Study | Entered Consolidation Phase | Midostaurin | 210 | |
| Overall Study | Entered Maintenance Phase | Midostaurin | 93 | |
| Overall Study | COMPLETED | Midostaurin | 52 | |
| Overall Study | NOT COMPLETED | Midostaurin | 249 |
Source ClinicalTrials.gov
Adverse events604
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Induction Phase | 34 | 301 | |
| other | Anaemia | Blood and lymphatic system disorders | Consolidation Phase | 36 | 210 | |
| other | Anaemia | Blood and lymphatic system disorders | Maintenance Phaase | 4 | 93 | |
| other | Anaemia | Blood and lymphatic system disorders | Overall | 52 | 301 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Induction Phase | 67 | 301 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Consolidation Phase | 44 | 210 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Maintenance Phaase | 0 | 93 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Overall | 88 | 301 | |
| other | Neutropenia | Blood and lymphatic system disorders | Induction Phase | 33 | 301 | |
| other | Neutropenia | Blood and lymphatic system disorders | Consolidation Phase | 50 | 210 |
1 to 10 of 604Source ClinicalTrials.gov
See all 604 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Induction Phase | 16 | 301 |
| Total, all-cause mortality | Consolidation Phase | 3 | 210 |
| Total, all-cause mortality | Maintenance Phaase | 0 | 93 |
| Total, all-cause mortality | Overall | 19 | 301 |
| Total, other adverse events | Induction Phase | 253 | 301 |
| Total, other adverse events | Consolidation Phase | 179 | 210 |
| Total, other adverse events | Maintenance Phaase | 48 | 93 |
| Total, other adverse events | Overall | 277 | 301 |
| Total, serious adverse events | Induction Phase | 76 | 301 |
| Total, serious adverse events | Consolidation Phase | 67 | 210 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37581981 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03379727
GET https://conductscience.org/api/trials/v1/NCT03379727/events?page=2