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NCT03795909 Clinical Trial

Ruxolitinib Combined With Dexamethasone for HLH

Hemophagocytic Lymphohistiocytosis Clinical Trial

Official title:
Ruxolitinib Combined With Dexamethasone for Pediatric Refractory and Secondary Hemophagocytic Lymphohistiocytosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03795909
Other study ID # HLH-DR
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 1, 2017
Est. completion date March 1, 2022

Study information
Verified date January 2019
Source Capital Research Institute of Pediatrics
Contact Yan Yue, MD
Phone 8618515238169
Email adaile123@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

A modified protocol about ruxolitinib combined with dexamethasone which includes oral 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 (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. Every 2 weeks, patients can be evaluated based the diagnosed index

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date March 1, 2022
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility Inclusion Criteria:

- Secondary and refractory HLH.

Exclusion Criteria:

- Family HLH.

Study Design

Related Conditions & MeSH terms

  • Hemophagocytic Lymphohistiocytosis
  • Lymphohistiocytosis, Hemophagocytic

Intervention

Drug:
• 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.

Locations
Country Name City State
China Yan Yue Beijing Chaoyang District
China Yan Yue Beijing

Sponsors (1)
Lead Sponsor Collaborator
Capital Research Institute of Pediatrics

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Severity of disease Serum ferritin>2000ng/ml, disease actvie; serum ferritin<2000ng/ml, disease control; 2 weeks
Secondary Axillary temperature 36 2 weeks
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