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ClinicalTrials.gov ID

NCT03795909

Lead Sponsor

Capital Research Institute of PediatricsOTHER_GOV

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 1Phase 2

Enrollment

50Estimated

Last Update Posted

Jan 8, 2019Actual

Start Date

Mar 1, 2017Actual

Primary Completion Date

Mar 1, 2020Estimated

Completion Date

Mar 1, 2022Estimated

Official Title

Ruxolitinib Combined With Dexamethasone for Pediatric Refractory and Secondary Hemophagocytic Lymphohistiocytosis

Brief Summary

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

Detailed 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

• Hemophagocytic Lymphohistiocytosis

• Ruxolitinib
• Dexamethasone

Ages Eligible for Study

Child (0-17)Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Secondary and refractory HLH.

Exclusion Criteria:

• Family HLH.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Sequential Assignment

Masking

Single

Lead Sponsor

Capital Research Institute of PediatricsOTHER_GOV

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