Trial · NCT01371981
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival (EFS) for Patients Without High Allelic Ratio FLT3/ITD+ Mutations | Up to 3 years | The Kaplan-Meier method will be used to estimate 3-year EFS, defined as the time from study entry until induction failure, relapse, secondary malignancy, or death. |
| Primary | EFS for Patients on Arm C, Cohort 1 | Up to 3 years | The Kaplan-Meier method will be used to estimate 3-year EFS, defined as the time from study entry until induction failure, relapse, secondary malignancy, or death. |
| Primary | EFS for Patients on Arm C, Cohort 2 | Up to 3 years | The Kaplan-Meier method will be used to estimate 3-year EFS, defined as the time from study entry until induction failure, relapse, secondary malignancy, or death. |
| Primary | EFS for Patients on Arm C, Cohort 3 | Up to 3 years | The Kaplan-Meier method will be used to estimate 3-year EFS, defined as the time from study entry until induction failure, relapse, secondary malignancy, or death. |
| Secondary | Overall Survival (OS) for Patients Without High Allelic Ratio FLT3/ITD+ Mutations | Up to 3 years | The Kaplan-Meier method will be used to estimate 3-year OS, defined as the time from study entry until death. |
| Secondary | OS for Patients on Arm C, Cohort 1 | Up to 3 years | The Kaplan-Meier method will be used to estimate 3-year OS, defined as the time from study entry until death. |
| Secondary | OS for Patients on Arm C, Cohort 2 | Up to 3 years | The Kaplan-Meier method will be used to estimate 3-year OS, defined as the time from study entry until death. |
| Secondary | OS for Patients on Arm C, Cohort 3 | Up to 3 years | The Kaplan-Meier method will be used to estimate 3-year OS, defined as the time from study entry until death. |
| Secondary | Relapse Rate for Patients Without High Allelic Ratio FLT3/ITD+ Mutations | Up to 3 years | Cumulative incidence estimates 3 year relapse rate defined as time from study entry to induction failure or relapse where deaths or secondary malignancies are competing events. |
| Secondary | Proportion of Patients Experiencing Grade 3 or Higher Non-hematologic Toxicities and Infections While on Protocol Therapy | Up to 2 years | The proportion of patients experiencing at least one grade 3 or higher non-hematologic toxicity and infection while on protocol therapy will be estimated along with the corresponding 95% confidence interval determined using a binomial exact method. Toxicity will be assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). |
| Secondary | Proportion of High Risk Children Without HR FLT3/ITD+ Converting From Positive MRD at End of Induction I to Negative MRD at the End of Induction II | Up to 8 weeks | The proportion of high risk children without HR FLT3/ITD+ converting from positive MRD at end of Induction I to negative MRD at the end of Induction II will be estimated as well as the corresponding 95% confidence interval determined using a binomial exact method. |
| Secondary | Total Scale Score From Parent-reported Pediatric Quality of Life Inventory Module | Up to 14 days | Results represent the total scale scores from the parent report of the PedsQL™ 4.0 Generic Core Scales for timepoint 1 (up to 14 days from start of therapy). Items are reverse-scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Therefore, a higher number is a better outcome. The total score is the sum of all the items divided by the number of items answered on all the scales. "Scores on a scale" is used for a unit of measure. |
| Secondary | Total Scale Score From Parent-reported Cancer Module | Up to 14 days | Results represent the total scale scores from the parent report of the PedsQL™ 3.0 Cancer Module for timepoint 1 (up to 14 days from start of therapy). Items are reverse-scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Therefore, a higher number is a better outcome. The total score is the sum of all the items divided by the number of items answered on all the scales. "Scores on a scale" is used for a unit of measure. |
| Secondary | Total Scale Score From Parent-reported Multidimensional Fatigue Scale Module | Up to 14 days | Results represent the total scale scores from the parent report of the PedsQL™ Multidimensional Fatigue Scale for timepoint 1 (up to 14 days from start of therapy). Items are reverse-scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Therefore, a higher number is a better outcome. The total score is the sum of all the items divided by the number of items answered on all the scales. "Scores on a scale" is used for a unit of measure. |
| Secondary | Bortezomib Clearance | Day 8 of Induction II | Median and range of bortezomib clearance during Induction II. |
| Secondary | Sorafenib Steady State Concentration | Up to 30 days | Median and range of sorafenib steady state concentration for Induction I. |
| Secondary | Change in Shortening Fraction | Up to 4 weeks | Mean percentage change in shortening fraction from baseline to the end of Induction I will be determined for eligible patients enrolled on Arms A, B and C. |
| Secondary | Change in Ejection Fraction | Up to 4 weeks | The mean percentage change in ejection fraction from baseline to the end of Induction I will be determined for eligible patients enrolled on Arms A, B and C. |
| Secondary | Serum Concentrations of GVHD Biomarker | Up to day 28 after SCT | The mean serum concentration of the day 28 GVHD biomarker will be estimated as well as the corresponding 95% confidence interval. |
| Other | Course Duration | Up to 6 months | Descriptive statistics will be used to summarize length of hospitalization time. |
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
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