Trial · NCT03836209
Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia
NCT03836209, Phase 2, Completed, PrECOG, LLC.; results first posted 2025-02-28
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia. Trials, record NCT03836209. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03836209
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia
- NCT number
- NCT03836209
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 181 participants, actual
- Lead sponsor
- PrECOG, LLC.
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Gilteritinib, Midostaurin, Daunorubicin, Cytarabine
- First posted
- 2019-02-11
- Last updated
- 2026-07-23
- Results first posted
- 2025-02-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | FLT3 Mutation Negative Composite Complete Response (CRc) [Includes Complete Response (CR) or CR With Incomplete Hematologic Recovery (CRi)] at End of Induction | 3 months | FLT3 mutation negative (evaluated by polymerase chain reaction \[PCR\]) Composite Complete Response (CRc) \[includes CR and CRi\] rate after induction treatment and complete MRD assessment. The cut points used for FLT3 mutation negative are 1% (equivalent to 10-2) for FLT3-TKD and 10-4 for FLT3-ITD. |
| Secondary | FLT3 Mutation Negative Complete Response (CR) Rate at End of Induction | 3 months | CR evaluated by FLT3 testing after Induction |
| Secondary | Minimal Residual Disease (MRD)- CRc Rate at End of Induction | 3 months | MRD- CRc evaluated by flow cytometry after Induction |
| Secondary | CRc (CR or CRi) Rate at End of Induction | 3 months | CRc assessed in accordance with 2017 European LeukemiaNet (ELN) |
| Secondary | Event Free Survival (EFS) | 68 months | EFS assessed in accordance with 2017 ELN |
| Secondary | Overall Survival (OS) | 68 months | OS assessed in accordance with 2017 ELN |
| Secondary | Number of Participants Treatment-related Adverse Events as Assessed by CTCAE v5.0 | 10 months | Number of participants with abnormal laboratory values and/or adverse events |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | FLT3 Mutation Negative Composite Complete Response (CRc) [Includes Complete Response (CR) or CR With Incomplete Hematologic Recovery (CRi)] at End of Induction | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | FLT3 Mutation Negative Complete Response (CR) Rate at End of Induction | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Minimal Residual Disease (MRD)- CRc Rate at End of Induction | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | CRc (CR or CRi) Rate at End of Induction | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Event Free Survival (EFS) | 68 months | |||
| SECONDARY | Overall Survival (OS) | 68 months | |||
| SECONDARY | Number of Participants Treatment-related Adverse Events as Assessed by CTCAE v5.0 | 10 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| FLT3 Mutation Negative Composite Complete Response (CRc) [Includes Complete Response (CR) or CR With Incomplete Hematologic Recovery (CRi)] at End of Induction | Arm A | 36 | Participants | ||
| FLT3 Mutation Negative Composite Complete Response (CRc) [Includes Complete Response (CR) or CR With Incomplete Hematologic Recovery (CRi)] at End of Induction | Arm B | 41 | Participants | ||
| FLT3 Mutation Negative Complete Response (CR) Rate at End of Induction | Arm A | 33 | Participants | ||
| FLT3 Mutation Negative Complete Response (CR) Rate at End of Induction | Arm B | 37 | Participants | ||
| Minimal Residual Disease (MRD)- CRc Rate at End of Induction | Arm A | 58 | Participants | ||
| Minimal Residual Disease (MRD)- CRc Rate at End of Induction | Arm B | 52 | Participants | ||
| CRc (CR or CRi) Rate at End of Induction | Arm A | 77 | Participants | ||
| CRc (CR or CRi) Rate at End of Induction | Arm B | 63 | Participants | ||
| Number of Participants Treatment-related Adverse Events as Assessed by CTCAE v5.0 | Arm A | 82 | Participants | ||
| Number of Participants Treatment-related Adverse Events as Assessed by CTCAE v5.0 | Arm B | 73 | 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 | Arm A | 90 | |
| Overall Study | STARTED | Arm B | 87 | |
| Overall Study | COMPLETED | Arm A | 10 | |
| Overall Study | COMPLETED | Arm B | 6 | |
| Overall Study | NOT COMPLETED | Arm A | 80 | |
| Overall Study | NOT COMPLETED | Arm B | 81 |
Source ClinicalTrials.gov
Adverse events246
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 | Alanine aminotransferase increased | Investigations | Arm A | 16 | 90 | 28 |
| other | Alanine aminotransferase increased | Investigations | Arm B | 18 | 87 | 36 |
| other | Anaemia | Blood and lymphatic system disorders | Arm A | 28 | 90 | 158 |
| other | Anaemia | Blood and lymphatic system disorders | Arm B | 34 | 87 | 168 |
| other | Aspartate aminotransferase increased | Investigations | Arm A | 17 | 90 | 24 |
| other | Aspartate aminotransferase increased | Investigations | Arm B | 24 | 87 | 28 |
| other | Colitis | Gastrointestinal disorders | Arm A | 7 | 90 | 8 |
| other | Colitis | Gastrointestinal disorders | Arm B | 5 | 87 | 5 |
| other | Constipation | Gastrointestinal disorders | Arm A | 22 | 90 | 23 |
| other | Constipation | Gastrointestinal disorders | Arm B | 9 | 87 | 13 |
1 to 10 of 246Source ClinicalTrials.gov
See all 246 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A | 23 | 90 |
| Total, all-cause mortality | Arm B | 27 | 87 |
| Total, other adverse events | Arm A | 83 | 90 |
| Total, other adverse events | Arm B | 81 | 87 |
| Total, serious adverse events | Arm A | 48 | 90 |
| Total, serious adverse events | Arm B | 39 | 87 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A vs Arm B: Minimal Residual Disease (MRD)- CRc Rate at End of Induction | Trial comparisons |
| Arm A vs Arm B: CRc (CR or CRi) Rate at End of Induction | Trial comparisons |
| Arm A vs Arm B: FLT3 Mutation Negative Complete Response (CR) Rate at End of Induction | Trial comparisons |
| Arm A vs Arm B: Number of Participants Treatment-related Adverse Events as Assessed by CTCAE v5.0 | Trial comparisons |
| Arm A vs Arm B: deaths from any cause | Trial comparisons |
| Arm A vs Arm B: FLT3 Mutation Negative Composite Complete Response (CRc) [Includes Complete Response (CR) or CR With Incomplete Hematologic Recovery (CRi)] at End of Induction | Trial comparisons |
| Arm A vs Arm B: serious adverse events | Trial comparisons |
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/NCT03836209
GET https://conductscience.org/api/trials/v1/NCT03836209/events?page=2