Trial · NCT04496999
HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt.
NCT04496999, Phase 1, Terminated, Insel Gruppe AG, University Hospital Bern
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt. Trials, record NCT04496999. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04496999
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt.
- NCT number
- NCT04496999
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 2 participants, actual
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Conditions
- AML, Adult
- Interventions
- HDM201, Midostaurin
- First posted
- 2020-08-04
- Last updated
- 2022-10-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose finding | 30 days | to identify the incidence of dose limiting toxicities (DLT) at each dose level and to determine the maximum tolerated dose (MTD) of HDM201 and its recommended dose that will be used in a later phase II study (recommended phase II dose; RP2D) when added to midostaurin |
| Secondary | Overall response rate (ORR) | 60 days | CR, CRi, CRp, PR including assessment of minimal residual disease by molecular diagnostics and flowcytometry after cycles 1 and 2. |
| Secondary | Adverse Events | 33 months | Number of patients experiencing adverse events and severity of the adverse events |
| Secondary | Progression free survival | 33 months | Time from end of treatment (after bone marrow assessment after cycle 2) until progression of disease or death as a result of any cause. |
| Secondary | Overall survival | 33 months | Time from end of treatment (after bone marrow assessment after cycle 2) until death as a result of any cause. |
| Secondary | Infectious complications of study treatment | 33 months | Assessment of the number of febrile episodes requiring antibiotic/antifungal treatment as well as assessment of identified causing germs. |
Source ClinicalTrials.gov
Outcomes0
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/NCT04496999
GET https://conductscience.org/api/trials/v1/NCT04496999/registered