Trial · NCT04027309
A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy
NCT04027309, Phase 3, Active not recruiting, Stichting Hemato-Oncologie voor Volwassenen Nederland
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy. Trials, record NCT04027309. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04027309
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy
- NCT number
- NCT04027309
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 777 participants, actual
- Lead sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts-2
- Interventions
- Gilteritinib, Midostaurin
- First posted
- 2019-07-19
- Last updated
- 2024-12-17
- Other registries' IDs
- eudract:2018-000624-33
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overal survival (OS) | Approximately up to 70 months following first patient enrolment | Overall survival (OS), defined as the time from date of randomization to the date of death due to any cause. Patients still alive or lost to follow up will be censored at the time they were last known to be alive. |
| Secondary | Event-free survival (EFS) | Approximately up to 70 months following first patient enrolment | Event-free survival (EFS), defined as the time from randomization to failure to achieve CR after remission induction, death or relapse after achieving CR, whichever occurs first. A patient is said to have failed to achieve CR after remission induction if his/her best response during or at completion of the induction therapy is less than CR. Patients who achieved CR after remission induction and are not known to have relapsed or died will be censored at the date of last clinical assessment. CR is determined by the Investigator according to the European LeukemiaNet (ELN2017) recommended response criteria. |
| Secondary | CR rate after remission induction | Approximately up to 70 months following first patient enrolment | CR rate after remission induction is defined as the percentage of patients with best response of CR during or at completion of induction therapy. |
| Secondary | EFS with modified CR (mEFS) | Approximately up to 70 months following first patient enrolment | EFS with modified CR (mEFS) is defined similarly to EFS above. It is the time from randomization to failure to achieve CR after remission induction, death or relapse after achieving CR, whichever occurs first. However, a patient will be considered to have failed to achieve CR after remission induction if CR is not achieved within 60 days after the start of the last induction cycle. Patients who achieve CR within 60 days of the start of the last induction cycle and are not known to have relapsed or died will be censored at the date of last clinical assessment. |
| Secondary | CR and CRi rates after induction cycle 1 and after induction cycle 2 | Approximately up to 70 months following first patient enrolment | CR and CRi are determined by the Investigator based on the European LeukemiaNet (ELN2017) recommended response criteria. |
| Secondary | Relapse-free survival (RFS) after CR | Approximately up to 70 months following first patient enrolment | RFS is defined as time from the date of achievement of CR as determined by the Investigator until relapse or death from any cause, whichever comes first. Patients still in first CR and alive or lost to follow up will be censored at the date of last clinical assessment. |
| Secondary | Cumulative incidence of relapse (CIR) after CR | Approximately up to 70 months following first patient enrolment | CIR is measured from the date of achievement of CR as determined by the Investigator until the date of relapse. Patients not known to have relapsed will be censored on the date of last clinical assessment. Patients who died without relapse will be counted as a competing cause of failure. |
| Secondary | Cumulative incidence of death (CID) after CR | Approximately up to 70 months following first patient enrolment | CID is measured from the date of achievement of CR as determined by the Investigator until the date of death from any cause. Patients not known to have died will be censored on the date they were last known to be alive. Patients who experienced relapse in CR will be counted as competing cause of failure. |
| Secondary | CR without minimal residual disease (CRMRD-) rate after induction cycle 2 | Approximately up to 70 months following first patient enrolment | CRMRD- rate is defined as the percentage of patients who achieved CR as determined by the Investigator with no evidence of MRD |
| Secondary | CR or CRi without minimal residual disease (CR/CRiMRD-) rate after induction cycle 2 | Approximately up to 70 months following first patient enrolment | CR or CRi without minimal residual disease (CR/CRiMRD-) rate after induction cycle 2, defined as the percentage of patients who achieved CR or CRi as determined by the Investigator with no evidence of MRD |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 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/NCT04027309
GET https://conductscience.org/api/trials/v1/NCT04027309/registered