Trial · NCT02883049
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | DFS of Non-DS HR Post-induction Patients Receiving Intrathecal (IT) Methotrexate (MTX) Compared With Patients Receiving Intrathecal Triple Therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) Interim Maintenance High-dose Methotrexate Backbone | At 5 years | Non-DS HR B-ALL patients with post induction therapies (includes patients from AALL0932). Inevaluable patients were excluded from analysis. | Percentage of patients | NUMBER |
| PRIMARY | DFS of Non-DS VHR Post-Induction Patients Who Receive a Modified MBFM-IMHDM Regimen That Contains a Second IM (Control Arm) Compared to Patients Receive the Cyclophosphamide + Etoposide Containing Regimen (Experimental Arm 1) | At 4 years | Non-DS VHR B-ALL patients with post induction therapies (includes patients from AALL0932). Inevaluable patients were excluded from analysis. | Percentage of patients | NUMBER |
| SECONDARY | Toxicity and Tolerability of Post-induction Age-adjusted ITT Compared to Age-adjusted IT MTX in Children With HR B-ALL | Up to 10 years | Patients risk assigned as HR B-ALL and randomized to the two post induction therapies (includes patients from AALL0932). Inevaluable and ineligible patients were excluded from analysis. | Percentage of patients | NUMBER |
| SECONDARY | Toxicity and Tolerability of Experimental Arm 1 and Control Arm in Patients With VHR B-ALL | Up to 10 years | (includes patients from AALL0932). Inevaluable and ineligible patients were excluded from analysis. | Percentage of patients | NUMBER |
| SECONDARY | Induction Mortality in Patients With DS and HR B-ALL Treated With Modified Induction | At 1 month | Patients with DS and HR B-ALL treated with modified Induction | Percentage of patients | NUMBER |
| SECONDARY | 5-year DFS in Patients With Down Syndrome (DS) and HR B-ALL Treated With Modified Induction and Post-Induction Therapy Regimen With MBFM-IMIDM | At 5 years | Patients with DS and HR B-ALL treated with modified Induction and post induction therapy with MBFM-IMIDM. Inevaluable patients were excluded from analysis | Percentage of patients | NUMBER |
| SECONDARY | DFS for Children and Young Adults With Ph-like B-ALL and a Predicted Tyrosine Kinase Inhibitor (TKI)-Sensitive Mutation Treated With Dasatinib Plus MBFM-IMHDM | Up to 4 years | Patients with Ph-like B-ALL and a predicted tyrosine kinase inhibitor (TKI)-sensitive mutation treated with dasatinib plus MBFM-IMHDM | Percentage of patients | NUMBER |
| SECONDARY | Toxicity and Tolerability of MBFM-interim Maintenance Intermediate Dose Methotrexate (IMIDM) in Children With Down Syndrome | Up to 10 years | DS patients received MBFM-interim maintenance intermediate dose methotrexate (includes patients from AALL0932). Inevaluable and ineligible patients were excluded from analysis. | Percentage of patients | NUMBER |
| SECONDARY | Overall Survival (OS) Rate for HR B-ALL Patients, Overall and by Randomized Arm | At 5 years | Total HR B-ALL patients (includes patients from AALL0932). Inevaluable and ineligible patients were excluded from analysis. | Percentage of patients | NUMBER |
| SECONDARY | Overall Survival (OS) Rate for VHR B-ALL Patients, Overall and by Randomized Arm. | At 4 years | VHR B-ALL patients with post induction therapies (includes patients from AALL0932). Experimental Arm 2 was closed early in the study due to excessive toxicities. The objectives and study design for VHR patients was modified to be limited to the two arms (Control vs Experimental Arm 1). Inevaluable and ineligible patients were also excluded from analysis. | Percentage of patients | NUMBER |
| SECONDARY | Incidence of Osteonecrosis (ON) Defined by Magnetic Resonance (MR) Imaging in Children, Adolescents, and Young Adults 10 Years of Age and Greater | Up to 10 years | HR and VHR patients that are 10 years or older with submitted MRI screening data. It was pre-specified in Study Protocol to collect and report data as a single Arm/Group for patients who met eligibility criteria for this correlative aim. Inevaluable and ineligible patients were excluded from analysis. | Percentage of patients | NUMBER |
| SECONDARY | The Prevalence of Cognitive Deficits Measured by CogState (Domain: Working Memory), in Children (Ages 6 to < 13 Years) With HR- and VHR B-ALL at 1 Year Off Therapy | Up to 10 years | It was pre-specified in Study Protocol to collect and report data as a single Arm/Group for patients who met eligibility criteria for this correlative aim. Inevaluable and ineligible patients were excluded from analysis. | percentage of participants | NUMBER |
| SECONDARY | The Prevalence of Cognitive Deficits Measured by CogState (Domain: Executive Function), in Children (Ages 6 to < 13 Years) With HR- and VHR B-ALL at 1 Year Off Therapy | Up to 10 years | It was pre-specified in Study Protocol to collect and report data as a single Arm/Group for patients who met eligibility criteria for this correlative aim . Inevaluable and ineligible patients were excluded from analysis. | percentage of participants | NUMBER |
| SECONDARY | The Prevalence of Cognitive Deficits Measured by CogState (Domain: Visual Learning), in Children (Ages 6 to < 13 Years) With HR- and VHR B-ALL at 1 Year Off Therapy | Up to 10 years | It was pre-specified in Study Protocol to collect and report data as a single Arm/Group for patients who met eligibility criteria for this correlative aim. Inevaluable and ineligible patients were excluded from analysis. | percentage of participants | NUMBER |
| SECONDARY | The Prevalence of Cognitive Deficits Measured by CogState (Domain: Processing Speed), in Children (Ages 6 to < 13 Years) With HR- and VHR B-ALL at 1 Year Off Therapy | Up to 10 years | It was pre-specified in Study Protocol to collect and report data as a single Arm/Group for patients who met eligibility criteria for this correlative aim. Inevaluable and ineligible patients were excluded from analysis. | percentage of participants | NUMBER |
| SECONDARY | The Prevalence of Cognitive Deficits Measured by CogState (Domain: Visual Attention), in Children (Ages 6 to < 13 Years) With HR- and VHR B-ALL at 1 Year Off Therapy | Up to 10 years | It was pre-specified in Study Protocol to collect and report data as a single Arm/Group for patients who met eligibility criteria for this correlative aim. Inevaluable and ineligible patients were excluded from analysis. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | The Reduction in MRD From End-Induction (EOI) to End-Consolidation (EOC) for Children, Adolescents, and Young Adults With VHR B-ALL Receiving Experimental Arms 1 Compared to the Control Arm | Up to 90 days |
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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