Trial · NCT01477606
Protocol in Acute Myeloid Leukemia With FLT3-ITD
NCT01477606, Phase 2, Completed, University of Ulm
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Protocol in Acute Myeloid Leukemia With FLT3-ITD. Trials, record NCT01477606. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01477606
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Protocol in Acute Myeloid Leukemia With FLT3-ITD
- NCT number
- NCT01477606
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 451 participants, actual
- Lead sponsor
- University of Ulm
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Midostaurin, Cytarabine, Daunorubicin
- First posted
- 2011-11-22
- Last updated
- 2020-06-04
- Other registries' IDs
- eudract:2011-003168-63
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT01477606
GET https://conductscience.org/api/trials/v1/NCT01477606/registered