Ruxolitinib Combined With Dexamethasone for HLH

Capital Research Institute of Pediatrics

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Hemophagocytic Lymphohistiocytosis

Treatments: Drug: Ruxolitinib; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT03795909

HLH-DR

Details and patient eligibility

About

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

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Secondary and refractory HLH.

Exclusion criteria

• Family HLH.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Ruxolitinib and Placebo

Experimental group

Description:

Ruxolitinib 2.5 mg twice daily by oral

Treatment:

Drug: Dexamethasone

Drug: Ruxolitinib

Placebo and Ruxolitinib

Placebo Comparator group

Description:

Sugar pill 2.5 mg twice daily by oral

Treatment:

Drug: Dexamethasone

Drug: Ruxolitinib