Trial · NCT01371981
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-free Survival (EFS) for Patients Without High Allelic Ratio FLT3/ITD+ Mutations | Up to 3 years | Patients ineligible, did not start treatment, or on Arm D are excluded from analyses of EFS. Arm D patients who were not eligible for Arm C by the end of induction I were declared off study per protocol; thus, no outcome data were collected for Arm D patients. Arms A and B are limited to patients without high allelic ratio FLT3/ITD+ mutations. | percentage of patients | NUMBER |
| PRIMARY | EFS for Patients on Arm C, Cohort 1 | Up to 3 years | Patients ineligible, did not start treatment, or on Arm D are excluded from analyses of EFS. Arm D patients who were not eligible for Arm C by the end of induction I were declared off study per protocol; thus, no outcome data were collected for Arm D patients. | percentage of patients | NUMBER |
| PRIMARY | EFS for Patients on Arm C, Cohort 2 | Up to 3 years | Patients ineligible, did not start treatment, or on Arm D are excluded from analyses of EFS. Arm D patients who were not eligible for Arm C by the end of induction I were declared off study per protocol; thus, no outcome data were collected for Arm D patients. | percentage of patients | NUMBER |
| PRIMARY | EFS for Patients on Arm C, Cohort 3 | Up to 3 years | Patients ineligible, did not start treatment, or on Arm D are excluded from analyses of EFS. Arm D patients who were not eligible for Arm C by the end of induction I were declared off study per protocol; thus, no outcome data were collected for Arm D patients. | percentage of patients | NUMBER |
| SECONDARY | Overall Survival (OS) for Patients Without High Allelic Ratio FLT3/ITD+ Mutations | Up to 3 years | Patients ineligible, did not start treatment, or on Arm D are excluded from analyses of OS. Arm D patients who were not eligible for Arm C by the end of induction I were declared off study per protocol; thus, no outcome data were collected for Arm D patients. Arms A and B are limited to patients without high allelic ratio FLT3/ITD+ mutations. | percentage of patients | NUMBER |
| SECONDARY | OS for Patients on Arm C, Cohort 1 | Up to 3 years | Patients ineligible, did not start treatment, or on Arm D are excluded from analyses of OS. Arm D patients who were not eligible for Arm C by the end of induction I were declared off study per protocol; thus, no outcome data were collected for Arm D patients. | percentage of patients | NUMBER |
| SECONDARY | OS for Patients on Arm C, Cohort 2 | Up to 3 years | Patients ineligible, did not start treatment, or on Arm D are excluded from analyses of OS. Arm D patients who were not eligible for Arm C by the end of induction I were declared off study per protocol; thus, no outcome data were collected for Arm D patients. | percentage of patients | NUMBER |
| SECONDARY | OS for Patients on Arm C, Cohort 3 | Up to 3 years | Patients ineligible, did not start treatment, or on Arm D are excluded from analyses of OS. Arm D patients who were not eligible for Arm C by the end of induction I were declared off study per protocol; thus, no outcome data were collected for Arm D patients. | percentage of patients | NUMBER |
| SECONDARY | Relapse Rate for Patients Without High Allelic Ratio FLT3/ITD+ Mutations | Up to 3 years | Patients ineligible, did not start treatment, or on Arms C or D are excluded. Arm D patients who were not eligible for Arm C by the end of induction I were declared off study per protocol; thus, no outcome data were collected for Arm D patients. Results are limited to patients on Arms A and B without high allelic ratio FLT3/ITD+ mutations. | percentage of patients | NUMBER |
| SECONDARY | Proportion of Patients Experiencing Grade 3 or Higher Non-hematologic Toxicities and Infections While on Protocol Therapy | Up to 2 years | Patients ineligible or who did not start treatment are excluded from results. | Proportion of patients | NUMBER |
| 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 | Patients ineligible, did not start treatment, on Arms C, D are excluded from results. Complete MRD results were not collected for Arm D patients due to being declared off study at end of induction I. Results limited to High Risk patients without high allelic ratio FLT3/ITD+ mutations and with evaluable MRD data from end of Induction I and II. | Proportion of patients | NUMBER |
| SECONDARY | Total Scale Score From Parent-reported Pediatric Quality of Life Inventory Module | Up to 14 days | Patients ineligible or who did not start treatment are excluded from results. Patients on Arms C (cohort 3) or Arm D are excluded due to enrolling post quality of life study accrual completion. Results are limited to only patients with an evaluable total scale score. | Scores on a scale | MEAN |
| SECONDARY | Total Scale Score From Parent-reported Cancer Module | Up to 14 days | Patients ineligible or who did not start treatment are excluded from results. Patients on Arms C (cohort 3) or Arm D are excluded due to enrolling post quality of life study accrual completion. Results are limited to only patients with an evaluable total scale score. | Scores on a scale | MEAN |
| SECONDARY | Total Scale Score From Parent-reported Multidimensional Fatigue Scale Module | Up to 14 days | Patients ineligible or who did not start treatment are excluded from results. Patients on Arms C (cohort 3) or Arm D are excluded due to enrolling post quality of life study accrual completion. Results are limited to only patients with an evaluable total scale score. | Scores on a scale | MEAN |
| SECONDARY | Bortezomib Clearance | Day 8 of Induction II | Only eligible patients on Arm B with evaluable Bortezomib PK clearance data during Induction II are reported. | Liters/hour/m^2 | MEDIAN |
| SECONDARY | Sorafenib Steady State Concentration | Up to 30 days | Data reported from Arm C were collected and analyzed regardless of the cohort as pre-specified in the study protocol. Only eligible patients on Arm C with evaluable Sorafenib steady state concentration data during Induction I are reported. | Nanogram/Milliliter | MEDIAN |
| SECONDARY | Change in Shortening Fraction | Up to 4 weeks | Patients ineligible, did not start treatment, or on Arm D are excluded from results. Shortening fraction data were not collected at end of Induction I for patients enrolled to Arm D. Results are limited to patients with evaluable shortening fraction data from study entry and at end of Induction I . | Percentage change | MEAN |
| SECONDARY | Change in Ejection Fraction | Up to 4 weeks | Patients ineligible, did not start treatment, or on Arm D are excluded from results. Ejection fraction data were not collected at end of Induction I for patients enrolled to Arm D. Results are limited to patients with evaluable ejection fraction data from study entry and at end of Induction I . | Percentage change | MEAN |
| SECONDARY | Serum Concentrations of GVHD Biomarker | Up to day 28 after SCT | Data were never collected | ||
| OTHER_PRE_SPECIFIED | Course Duration | Up to 6 months |
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/NCT01371981/outcomes