Trial · NCT02013648
Randomized Phase III Study of Intensive Chemotherapy With or Without Dasatinib (Sprycel™)
NCT02013648, Phase 3, Completed, University of Ulm
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Phase III Study of Intensive Chemotherapy With or Without Dasatinib (Sprycel™). Trials, record NCT02013648. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02013648
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Phase III Study of Intensive Chemotherapy With or Without Dasatinib (Sprycel™)
- NCT number
- NCT02013648
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 204 participants, actual
- Lead sponsor
- University of Ulm
- Conditions
- Acute Myeloid Leukemia (AML)
- Interventions
- Dasatinib, Cytarabine, Daunorubicin, Idarubicin
- First posted
- 2013-12-17
- Last updated
- 2024-02-23
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival | 4 years | To assess event-free survival (EFS) after intensive induction (daunorubicin and cytarabine) and consolidation (high-dose cytarabine) chemotherapy with or without dasatinib in patients with CBF-AML |
| Secondary | Cumulative incidence of relapse (CIR) | 4 years | |
| Secondary | Cumulative incidence of death (CID) | 4 years | |
| Secondary | overall survival | 4 years | |
| Secondary | relapse-free survival | 4 years | |
| Secondary | PIA analysis | 4 years | Pharmacodynamic inhibition of KIT as assessed by the KIT plasma inhibitory assay (PIA) |
| Secondary | toxicity | 7 months (standard arm) / 19 months (investigational arm) | Type, frequency, severity (graded using the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 4.03), timing and relatedness of non-hematologic toxicity observed during different treatment cycles. |
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.
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/NCT02013648
GET https://conductscience.org/api/trials/v1/NCT02013648/registered