Trial · NCT04097470
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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. |
| Secondary | Prognostic value of baseline functional conditions as measured by the activities of daily living | 5 years | Assessment of the prognostic value of baseline functional conditions using a comprehensive geriatric assessment tool, activities of daily living (ADL), on treatment outcome. Total points (range 0 to 6) will be used to determine functional condition. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT04097470/registered