Trial · NCT01477606
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival | 8years | To perform two predefined subgroup analyses in the age-groups 18-60 years and 61-70 years evaluating the impact of midostaurin given in combination with intensive induction, consolidation including allogeneic hematopoietic stem cell transplantation and single agent maintenance therapy on event-free survival (EFS) in adult patients with AML exhibiting a FLT3-ITD. |
| Secondary | Rate of complete remission (CR) | Two months | |
| Secondary | Relapse-free survival | 8 years | |
| Secondary | overall survival | 8 years | |
| Secondary | Cumulative incidence of relapse | 8 years | |
| Secondary | cumulative incidence of death in CR | 8 years | |
| Secondary | Target (FLT3) inhibition by measuring the FLT3 plasma inhibitory activity | 8 years | Evaluation of target (FLT3) inhibition by continuous dosing of midostaurin |
| Secondary | Quality of life | 5 years | Quality of life assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases, late treatment effects, and demographics initially, in first CR, after one year,3 and 5 years after initial diagnosis. |
| Secondary | Rate of early deaths and hypoplastic deaths (ED/HD) | two months | |
| Secondary | Death in CR | 8 years | |
| Secondary | Toxicities | between 18 and 24 months | Type, frequency, severity (graded using the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version 3.0), timing and relatedness of hematological and non-hematological toxicities observed during the different treatment cycles |
| Secondary | Impact of allogeneic HSCT | 8 years | Assessment of the relative impact of allogeneic HSCT analyzed as time-dependent variable on survival endpoints. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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/NCT01477606/registered