Trial · NCT03512197
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)
NCT03512197, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2023-06-18
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. 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). Trials, record NCT03512197. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03512197
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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)
- NCT number
- NCT03512197
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 511 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Acute Myeloid Leukemia (AML)
- Interventions
- Midostaurin, Placebo, Chemotherapy
- First posted
- 2018-04-30
- Last updated
- 2023-08-21
- Other registries' IDs
- eudract:2017-003540-21
- Results first posted
- 2023-06-18
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event Free Survival (EFS) | From date of Randomization up to approx. 30 months | 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. |
| Secondary | Overall Survival (OS) (Key Secondary) | Between randomization to date of death up to approx. 30 months | OS was defined as the time from randomization to date of death due to any cause. Patients entered the survival follow-up phase once they completed the safety follow up period (30 days after the last dose of midostaurin/placebo) in case of induction failure or if they had relapsed during post-treatment follow-up. Patients were then contacted by telephone every 3 months +/- 2 weeks or had a visit to follow up on their survival status, per Kaplan-Meier estimates. |
| Secondary | Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Hematological Recovery (CRi) But With Adequate Blood Count Recovery Rate. | At maximum 93 days from induction therapy start | Assessment was based on the International Working Group (IWG) criteria for AML as per investigator assessment. CR: Bone marrow: \< 5% blasts no blasts with Auer rods; Peripheral blood: neutrophils ≥ 1.0 x 109/L platelets ≥ 100 x 109/L, no blasts; No evidence of extramedullary disease (such as central nervous system (CNS) or soft tissue involvement); Transfusion independent. CRi with adequate blood count recovery is defined as the following: Bone marrow \< 5% blasts no blasts with Auer rods Peripheral blood Neutrophils \>= 1.0 x 109/L and 50 x 109/L \<=platelets \< 100 x 109/L no blasts No evidence of extramedullary disease (such as CNS or soft tissue involvement). |
| Secondary | Percentage of Participants With Minimal Residual Disease (MRD) Negative Status | from start of treatment up to end of post-consolidation (approximately 17 months) | MRD- rate was defined as the rate of participants reaching MRD at any timepoint. Participants with leukemic blasts below 0.1% were considered as MRD-negative based on leukemia-associated immunophenotype (LAIP). MRD was derived from bone marrow and blood data using cellular and molecular technologies and MRD status was measured using the flow cytometry assessments for LAIP irrespective of the investigator's overall clinical response assessment. |
| Secondary | Percentage of Participants With Minimal Residual Disease (MRD) Negative Status During Post-consolidation Phase | from start of post-consolidation to end of post-consolidation phase (up to 12 months) | MRD- rate was defined as the rate of participants reaching MRD at any timepoint during Post-consolidation phase. Participants with leukemic blasts below 0.1% were considered as MRD-negative based on leukemia-associated immunophenotype (LAIP). MRD was derived from bone marrow and blood data using cellular and molecular technologies and MRD status was measured using the flow cytometry assessments for LAIP irrespective of the investigator's overall clinical response assessment. |
| Secondary | Time to Measurable Residual Disease (MRD) Negativity by Flow Cytometry | From date of Randomization up to approx. 17 months | Time to MRD- is defined as time from randomization to first occurrence of MRD-. Participants with leukemic blasts below 0.1% were considered as MRD-negative based on leukemia-associated immunophenotype (LAIP). MRD was derived from bone marrow and blood data using cellular and molecular technologies and MRD status was measured using the flow cytometry assessments for LAIP irrespective of the investigator's overall clinical response assessment. |
| Secondary | Disease-free Survival (DFS) | From date of CR or CRi with adequate blood count recovery up to approx. 30 months | DFS as measured from the date of first CR or CRi with adequate blood count recovery to relapse or death due to any cause, whichever occurred first. Participants who did not relapse nor die were censored at the last adequate response assessment. Assessment was based on the IWG criteria for AML as per investigator assessment |
| Secondary | Cumulative Incidence of Relapse (CIR) | From date of CR or CRi with adequate blood count recovery up to approx. 30 months | Cumulative Incidence of Relapse (CIR) was defined for participants with CR or CRi with adequate blood count recovery and was the time from achieving the CR or CRi with adequate blood count recovery until the onset of relapse from CR or CRi with adequate blood recovery. Participants without relapse were censored at the last adequate response assessment. Participants who died without relapse were counted as a competing cause of failure. |
| Secondary | Cumulative Incidence of Death (CID) | From date of CR or CRi with adequate blood count recovery up to approx. 30 months | Cumulative Incidence of Death (CID) was defined for all participants achieving CR or CRi with adequate blood count recovery measured from the date of achievement of CR or CRi until the date of death due to any reason. Participants not known to have died were censored on the last contact date. Participants who experienced relapse were counted as a competing cause of failure. |
| Secondary | Time to CR or CRi With Adequate Blood Count Recovery | At maximum 93 days from induction therapy start | Time to CR or CRi with adequate blood count recovery was defined as the time from randomization to CR or CRi with adequate blood count recovery whichever occurred first |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event Free Survival (EFS) | From date of Randomization up to approx. 30 months | Full analysis set comprised all participants to whom study drug was assigned by randomization. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) (Key Secondary) | Between randomization to date of death up to approx. 30 months | Full analysis set comprised all participants to whom study drug was assigned by randomization. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Hematological Recovery (CRi) But With Adequate Blood Count Recovery Rate. | At maximum 93 days from induction therapy start | Full analysis set comprised all participants to whom study drug was assigned by randomization. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Minimal Residual Disease (MRD) Negative Status | from start of treatment up to end of post-consolidation (approximately 17 months) | Full analysis set comprised all participants to whom study drug was assigned by randomization. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Minimal Residual Disease (MRD) Negative Status During Post-consolidation Phase | from start of post-consolidation to end of post-consolidation phase (up to 12 months) | Full analysis in post-consolidation phase comprised of participants who entered post-consolidation phase | Percentage of participants | NUMBER |
| SECONDARY | Time to Measurable Residual Disease (MRD) Negativity by Flow Cytometry | From date of Randomization up to approx. 17 months | Analysis set comprised all participants to whom study drug was assigned by randomization. | Days | MEDIAN |
| SECONDARY | Disease-free Survival (DFS) | From date of CR or CRi with adequate blood count recovery up to approx. 30 months | Full analysis set comprised all participants to whom study drug was assigned by randomization. DFW was derived only for participants who reached CR or CRi with adequate blood count recovery in induction (during first 93 days). | Months | MEDIAN |
| SECONDARY | Cumulative Incidence of Relapse (CIR) | From date of CR or CRi with adequate blood count recovery up to approx. 30 months | Full analysis set comprised all participants to whom study drug was assigned by randomization. CIR was only for participants who achieved CR or CRi with adequate blood count recovery. | Months | MEDIAN |
| SECONDARY | Cumulative Incidence of Death (CID) | From date of CR or CRi with adequate blood count recovery up to approx. 30 months | Full analysis set comprised all participants to whom study drug was assigned by randomization. CID was only for participants who achieved CR or CRi with adequate blood count recovery. | Months | MEDIAN |
| SECONDARY | Time to CR or CRi With Adequate Blood Count Recovery | At maximum 93 days from induction therapy start | Full analysis set comprised all participants to whom study drug was assigned by randomization. | Days | MEDIAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group181
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event Free Survival (EFS) | Midostaurin + Chemotherapy | 5.98 | 95% Confidence Interval 2.33 to 8.97 | Months | |
| Event Free Survival (EFS) | Placebo + Chemotherapy | 5.88 | 95% Confidence Interval 3.65 to 7.52 | Months | |
| Overall Survival (OS) (Key Secondary) | Midostaurin + Chemotherapy | NA | 95% Confidence Interval 15.54 to NA | Months | |
| Overall Survival (OS) (Key Secondary) | Placebo + Chemotherapy | 19.22 | 95% Confidence Interval 13.8 to NA | Months | |
| Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Hematological Recovery (CRi) But With Adequate Blood Count Recovery Rate. | Midostaurin + Chemotherapy | 59.2 | 95% Confidence Interval 52.8 to 65.4 | Percentage of participants | |
| Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Hematological Recovery (CRi) But With Adequate Blood Count Recovery Rate. | Placebo + Chemotherapy | 61.0 | 95% Confidence Interval 54.6 to 67.0 | Percentage of participants | |
| Percentage of Participants With Minimal Residual Disease (MRD) Negative Status | Midostaurin + Chemotherapy | 40.8 | Percentage of participants | ||
| Percentage of Participants With Minimal Residual Disease (MRD) Negative Status | Placebo + Chemotherapy | 41.0 | Percentage of participants | ||
| Percentage of Participants With Minimal Residual Disease (MRD) Negative Status During Post-consolidation Phase | Midostaurin + Chemotherapy | 33.3 | Percentage of participants | ||
| Percentage of Participants With Minimal Residual Disease (MRD) Negative Status During Post-consolidation Phase | Placebo + Chemotherapy | 33.3 | Percentage of participants |
1 to 10 of 181Source ClinicalTrials.gov
See all 181 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Midostaurin + Chemotherapy | 250 | |
| Overall Study | STARTED | Placebo + Chemotherapy | 251 | |
| Overall Study | Treated With Midostaurin/Placebo | Midostaurin + Chemotherapy | 245 | |
| Overall Study | Treated With Midostaurin/Placebo | Placebo + Chemotherapy | 249 | |
| Overall Study | Entered Induction Phase | Midostaurin + Chemotherapy | 250 | |
| Overall Study | Entered Induction Phase | Placebo + Chemotherapy | 251 | |
| Overall Study | Entered Consolidation Phase | Midostaurin + Chemotherapy | 120 | |
| Overall Study | Entered Consolidation Phase | Placebo + Chemotherapy | 129 | |
| Overall Study | Entered Post-Consolidation Phase | Midostaurin + Chemotherapy | 45 | |
| Overall Study | Entered Post-Consolidation Phase | Placebo + Chemotherapy | 27 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events900
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 | Midostaurin + Chemotherapy (On-treatment) | 77 | 245 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Chemotherapy (On-treatment) | 96 | 249 | |
| other | Anaemia | Blood and lymphatic system disorders | Midostaurin + Chemotherapy (Post-treatment Survival Follow-up) | 0 | 0 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Chemotherapy (Post-treatment Survival Follow-up) | 0 | 0 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Midostaurin + Chemotherapy (On-treatment) | 102 | 245 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Placebo + Chemotherapy (On-treatment) | 116 | 249 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Midostaurin + Chemotherapy (Post-treatment Survival Follow-up) | 0 | ||
| other | Febrile neutropenia | Blood and lymphatic system disorders | Placebo + Chemotherapy (Post-treatment Survival Follow-up) | 0 | ||
| other | Leukopenia | Blood and lymphatic system disorders | Midostaurin + Chemotherapy (On-treatment) | 20 | 245 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo + Chemotherapy (On-treatment) | 31 | 249 |
1 to 10 of 900Source ClinicalTrials.gov
See all 900 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Midostaurin + Chemotherapy (On-treatment) | 25 | 245 |
| Total, all-cause mortality | Placebo + Chemotherapy (On-treatment) | 21 | 249 |
| Total, all-cause mortality | Midostaurin + Chemotherapy (Post-treatment Survival Follow-up) | 21 | 220 |
| Total, all-cause mortality | Placebo + Chemotherapy (Post-treatment Survival Follow-up) | 32 | 228 |
| Total, other adverse events | Midostaurin + Chemotherapy (On-treatment) | 242 | 245 |
| Total, other adverse events | Placebo + Chemotherapy (On-treatment) | 245 | 249 |
| Total, other adverse events | Midostaurin + Chemotherapy (Post-treatment Survival Follow-up) | 0 | 0 |
| Total, other adverse events | Placebo + Chemotherapy (Post-treatment Survival Follow-up) | 0 | 0 |
| Total, serious adverse events | Midostaurin + Chemotherapy (On-treatment) | 95 | 245 |
| Total, serious adverse events | Placebo + Chemotherapy (On-treatment) | 114 | 249 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41432755 | 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/NCT03512197
GET https://conductscience.org/api/trials/v1/NCT03512197/results?page=2