Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2017-03-01
2022-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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Ruxolitinib and Placebo
Ruxolitinib 2.5 mg twice daily by oral
Ruxolitinib
Ruxolitinib （2.5 mg twice daily for patients if the age\<14 years and the weight \<25kg，5 mg twice daily for patients if the age\<14 years and the weight≥25kg, 10mg twice daily for patients if the age ≥14 years and\<18 years）
Dexamethasone
Dexamethasone (10mg/m2.d) delayes for the first 2 weeks（form week 1 to 2),(5mg/m2.d) from week 3 to 4，(2.5mg/m2.d) from week 5 to 6），1.25mg/m2.d for week 7，and dropped off on week 8.
Placebo and Ruxolitinib
Sugar pill 2.5 mg twice daily by oral
Ruxolitinib
Ruxolitinib （2.5 mg twice daily for patients if the age\<14 years and the weight \<25kg，5 mg twice daily for patients if the age\<14 years and the weight≥25kg, 10mg twice daily for patients if the age ≥14 years and\<18 years）
Dexamethasone
Dexamethasone (10mg/m2.d) delayes for the first 2 weeks（form week 1 to 2),(5mg/m2.d) from week 3 to 4，(2.5mg/m2.d) from week 5 to 6），1.25mg/m2.d for week 7，and dropped off on week 8.
Interventions
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Ruxolitinib
Ruxolitinib （2.5 mg twice daily for patients if the age\<14 years and the weight \<25kg，5 mg twice daily for patients if the age\<14 years and the weight≥25kg, 10mg twice daily for patients if the age ≥14 years and\<18 years）
Dexamethasone
Dexamethasone (10mg/m2.d) delayes for the first 2 weeks（form week 1 to 2),(5mg/m2.d) from week 3 to 4，(2.5mg/m2.d) from week 5 to 6），1.25mg/m2.d for week 7，and dropped off on week 8.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Year
18 Years
ALL
No
Sponsors
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Capital Research Institute of Pediatrics
OTHER_GOV
Responsible Party
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Yan Yue
Principal Investigator
Principal Investigators
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Yan Yue, MD
Role: PRINCIPAL_INVESTIGATOR
Capital Institute of Pediatrics, China
Locations
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Yan Yue
Beijing, Chaoyang District, China
Yan Yue
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HLH-DR
Identifier Type: -
Identifier Source: org_study_id
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