Interventional study
disjoint with: Nothing
subclass of: Thing
type: Class

Quantitative human study
disjoint with: Nothing
subclass of: Thing
type: Class

has_intervention
preferred label: Intervention
IAO_0000111: Intervention Type
type: Thing
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Clinical Protocol & Data Management Shared Resource
type: Thing

Published
type: Thing

Berenberg, Jeffrey
type: Thing

has_subject_area
preferred label: Additional Topic(s)
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Children's Oncology Group
type: Thing

has_url
preferred label: Website(s)
IAO_0000111: has URL
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nvasilevsky
type: Thing

has_study_population
preferred label: Study Population
IAO_0000111: study population
type: Thing
sub property of: topDataProperty
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Bortezomib and combination chemotherapy in treating younger patients with recurrent, refractory, or secondary acute myeloid leukemia
has_topic: Leukemia, Myeloid, Acute
created: 2011-06-23T01:25:42.899Z
has_phase: Phase 2
type: Thing
type: Interventional study
type: processual_entity
resource_description: The primary objectives of this study are to determine the toxicities and tolerability of bortezomib in combination with standard-relapse acute myeloid leukemia (AML) therapy (idarubicin/cytarabine or etoposide/high-dose cytarabine) in pediatric and young adult patients with relapsed or primary-refractory or secondary AML, and to estimate the complete response rate to the Arm A and Arm B regimens. This is a multicenter, dose-escalation study of bortezomib. Patients are stratified according to anthracycline-equivalent cumulative exposure (≤ 400 mg/m² vs > 400 mg/m²). Patients are assigned to 1 of 2 groups. Group 1 (efficacy phase, patients with ≤ 400 mg/m² anthracycline-equivalent cumulative exposure): Patients receive idarubicin IV over 15 minutes on days 1-3, low-dose cytarabine IV continuously over days 1-7, and bortezomib IV on days 1, 4, and 8. Group 2 (dose-finding phase and efficacy phase, patients with > 400 mg/m² anthracycline-equivalent cumulative exposure): Patients receive etoposide IV over 1 hour on days 1-5, high-dose cytarabine IV over 1 hour twice daily on days 1-5, and bortezomib IV on days 1, 4, and 8. All patients receive intrathecal cytarabine prior to courses 1 and 2. In both arms, treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically for at least 5 years.
type: entity
has_subject_area: antineoplastic combination chemotherapy
type: planned process
has_url: http://www.cancer.gov/clinicaltrials/search/view
workflow state: Published
has_study_population: 90 males and females 1 to 21 years of age.
type: clinical trial
type: research project
CTurl: http://www.clinicaltrial.gov/ct2/show/NCT00666588
type: occurrent
type: Quantitative human study
type: human study
modified: 2011-09-23T15:52:44.509Z
eagle-i_synonym: Phase II Pilot Study of Bortezomib (PS-341, Velcade) Combined With Reinduction Chemotherapy in Children and Young Adults With Recurrent, Refractory or Secondary Acute Myeloid Leukemi

Phase 2
preferred label: Phase 2 clinical trial
type: Thing

processual_entity
disjoint with: Nothing
subclass of: Thing
type: Class

workflow state
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clinical trial
preferred label: Clinical trial
type: Thing
disjoint with: Nothing
subclass of: Thing
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Leukemia, Myeloid, Acute
type: Thing

funded_by
preferred label: Funded by
IAO_0000111: funded by
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planned process
IAO_0000111: planned process
type: Thing
disjoint with: Nothing
subclass of: Thing
type: Class

CTurl
preferred label: ClinicalTrials.gov url
IAO_0000111: ClinicalTrials.gov url
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sub property of: topDataProperty
property disjoint with: bottomDataProperty
type: DatatypeProperty

Wilkinson, Robert, M.D.
type: Thing

Idarubicin/cytarabine
type: intervention
type: entity
type: planned process
type: processual_entity
type: drug intervention
type: Thing
type: occurrent

human_study_performed_by
preferred label: Performed by
IAO_0000111: human study performed by
type: Thing
sub property of: topObjectProperty
property disjoint with: bottomObjectProperty
type: ObjectProperty

resource_description
preferred label: Resource Description
type: Thing
sub property of: topDataProperty
property disjoint with: bottomDataProperty
type: DatatypeProperty

entity
disjoint with: Nothing
subclass of: Thing
type: Class

human study
preferred label: Human Study
IAO_0000111: human study
type: Thing
disjoint with: Nothing
subclass of: Thing
type: Class

has_PI
preferred label: PI
IAO_0000111: has PI
type: Thing
sub property of: topObjectProperty
property disjoint with: bottomObjectProperty
type: ObjectProperty

eagle-i_synonym
preferred label: Additional Name
type: Thing
sub property of: topDataProperty
property disjoint with: bottomDataProperty
type: DatatypeProperty

mwilson (Melanie Wilson)
type: Thing

drug intervention
preferred label: Drug intervention
IAO_0000111: drug intervention
type: Thing
disjoint with: Nothing
subclass of: Thing
type: Class

Etoposide/cytarabine
type: intervention
type: entity
type: planned process
type: processual_entity
type: drug intervention
type: Thing
type: occurrent

occurrent
disjoint with: Nothing
subclass of: Thing
type: Class

research project
preferred label: Research project
type: Thing
disjoint with: Nothing
subclass of: Thing
type: Class

has_phase
preferred label: Phase
IAO_0000111: has phase
type: Thing
sub property of: topObjectProperty
property disjoint with: bottomObjectProperty
type: ObjectProperty

intervention
preferred label: Intervention
type: Thing
disjoint with: Nothing
subclass of: Thing
type: Class

has_topic
preferred label: Topic
IAO_0000111: has topic
type: Thing
sub property of: topObjectProperty
property disjoint with: bottomObjectProperty
type: ObjectProperty

awendicke (Annemarie Wendicke)
type: Thing

has_contact
preferred label: Contact
IAO_0000111: has contact
type: Thing
sub property of: topObjectProperty
property disjoint with: bottomObjectProperty
type: ObjectProperty

Bortezomib
type: intervention
type: entity
type: planned process
type: processual_entity
type: drug intervention
type: Thing
type: occurrent