Ruxolitinib Combined With Dexamethasone for HLH

Sponsor
Capital Research Institute of Pediatrics
Study ID
NCT03795909
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Hemophagocytic Lymphohistiocytosis

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    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 — DRUG
    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.

Study Details

A protocol named as "HLH-DR" for patients with refractory and secondary hemophagocytic lymphohistiocytosismay.

Key Dates

Start date
Mar 1, 2017
Status verified
Jan 2019
Primary completion
Mar 1, 2020
Completion
Mar 1, 2022

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib and Placebo
    Ruxolitinib 2.5 mg twice daily by oral
  • Placebo Comparator: Placebo and Ruxolitinib
    Sugar pill 2.5 mg twice daily by oral

Primary Outcome Measure

Severity of disease [ Time Frame: 2 weeks ]

Central Contacts

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