Trial · NCT01190930
Registered outcomes49
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 49
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization | 5.7 years | DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated. |
| Primary | DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization | 5.7 years | DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated. |
| Primary | DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens | 5.1 years | DFS is calculated as the time from randomization at the end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated. |
| Primary | DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care | 5.1 years | DFS is calculated as the time from end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. The 5-year DFS and 95% confidence interval for these patients will be estimated. |
| Primary | Sample Collection of Central Path Review Slides in B-LLy Patients | Up to 1 month | Percent of B-LLy patients who had adequate/usable samples of samples collected will be reported. |
| Primary | Event Free Survival (EFS) for B-LLy Patients | 5 years | EFS is calculated as the Time from study enrollment to first event (induction failure, relapse, second malignancy, remission death) or date of last contact. The 5-year EFS and 95% confidence interval for these patients will be estimated. |
| Primary | Overall Survival (OS) for B-LLy Patients | 5 years | OS is calculated as the time from study enrollment to death or date of last contact. The 5-year OS and 95% confidence interval for these patients will be estimated. |
| Secondary | Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional | 2 Months | Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. |
| Secondary | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional | 1 year | Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. |
| Secondary | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional | 1.7 years | Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. |
| Secondary | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional | 2.5 years | Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. |
| Secondary | Burden of Therapy in Boy AR Patients Overall at End of Therapy: Emotional | 3.2 years | Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Genetic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. |
| Secondary | Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical | 2 Months | Age and gender standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. |
| Secondary | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Physical | 1 Year | Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. |
| Secondary | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Physical | 1.7 years | Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. |
| Secondary | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical | 2.4 Years | Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. |
| Secondary | Burden of Therapy in Boy AR Patients Overall at End of Therapy: Physical | 3.2 years | Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. |
| Secondary | Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: School | 2 Months | Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. |
| Secondary | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: School | 1 Year | Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. |
| Secondary | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: School | 1.7 Years | Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. |
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.
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