Trial · NCT04097470
Tolerability and Efficacy of Midostaurin to 10-day Decitabine in Unfit Adult AML and High Risk MDS Patients
NCT04097470, Phase 2, Active not recruiting, Stichting Hemato-Oncologie voor Volwassenen Nederland
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Tolerability and Efficacy of Midostaurin to 10-day Decitabine in Unfit Adult AML and High Risk MDS Patients. Trials, record NCT04097470. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04097470
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tolerability and Efficacy of Midostaurin to 10-day Decitabine in Unfit Adult AML and High Risk MDS Patients
- NCT number
- NCT04097470
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 140 participants, actual
- Lead sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland
- Conditions
- AML/MDS
- Interventions
- Decitabine, Midostaurin
- First posted
- 2019-09-20
- Last updated
- 2024-09-19
- Other registries' IDs
- eudract:2018-000047-31
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative Complete Remission (CR) / CR with incomplete blood count (CRi) rate | 4-5 months | Cumulative CR/CRi rate during 3 cycles |
| Secondary | Safety and tolerability of midostaurin determined by the type, frequency, severity and relationship of adverse events to study treatment | 5 years | Safety and tolerability of midostaurin added to 10-day decitabine treatment for AML (type, frequency, severity and relationship of adverse events to study treatment). |
| Secondary | Efficacy profile | 4-9 months | The response rate after first three cycles together with the best response during three cycles and after 9 months will determinine the efficacy profile. |
| Secondary | Event free survival (EFS) | 5 years | The time from registration to induction failure, death or relapse whichever occurs first). |
| Secondary | Overall survival (OS) | 5 years | The time from the date of randomization to the date of death, whatever the cause. Patients still alive at the date last contact will be censored. |
| Secondary | Hospital stay duration | 4-5 months | Days of staying in hospital during 3 cycles. |
| Secondary | Transfusion need | 4-5 months | Number of participants with transfusion needs during 3 cycles. |
| Secondary | Prognostic value of MRD | 9 months and at relapse | Assessment of the prognostic value of Minimal Residual Disease (MRD) by flowcytometry or PCR |
| Secondary | Predictive value of gene mutations | 5 years | Assessment of the predictive value of gene mutations by exploratory analysis |
| Secondary | Prognostic value of baseline physical conditions as measured by the short physical performance battery | 5 years | Assessment of the prognostic value of baseline physical and functional conditions using a comprehensive geriatric assessment tool, short physical performance battery (SPPB), on treatment outcome. Total scores (range 0 to 12) will be used to determine physical performance. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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/NCT04097470
GET https://conductscience.org/api/trials/v1/NCT04097470/registered