Ruxolitinib Combined With Dexamethasone for HLH

Ruxolitinib Combined With Dexamethasone for Pediatric Refractory and Secondary Hemophagocytic Lymphohistiocytosis

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03795909

Enrollment

Registered

2019-01-08

Start date

2017-03-01

Completion date

2022-03-01

Last updated

2019-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

DRUGRuxolitinib

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）

DRUGDexamethasone

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 design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

Healthy volunteers

Inclusion criteria

* Secondary and refractory HLH.

Exclusion criteria

* Family HLH.

Design outcomes

Primary

Measure	Time frame	Description
Severity of disease	2 weeks	Serum ferritin\>2000ng/ml, disease actvie; serum ferritin\<2000ng/ml, disease control;

Secondary

Measure	Time frame	Description
Axillary temperature	2 weeks	36\<Axillary temperature\<37.2, disease control; 37.2\<Axillary temperature\<38.2, disease partly control; Axillary temperature\>38.2, disease active

Countries

China

Contacts

Primary ContactYan Yue, MD

adaile123@sina.com8618515238169

Backup Contactxiaodong d Shi, MD

18611196921@163.com8613911601076

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026