Ruxolitinib Combined With Dexamethasone for HLH

January 5, 2019 updated by: Yan Yue, Capital Research Institute of Pediatrics

Ruxolitinib Combined With Dexamethasone for Pediatric Refractory and Secondary Hemophagocytic Lymphohistiocytosis

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Yan Yue
        • Contact:
        • Contact:
    • Chaoyang District
      • Beijing, Chaoyang District, China, 100020
        • Recruiting
        • Yan Yue
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jia Y Qin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Secondary and refractory HLH.

Exclusion Criteria:

  • Family HLH.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ruxolitinib and Placebo
Ruxolitinib 2.5 mg twice daily by oral
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）
Other Names:
  • Jakafi
Drug: 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.
Other Names:
  • Hormone
Placebo Comparator: Placebo and Ruxolitinib
Sugar pill 2.5 mg twice daily by oral
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）
Other Names:
  • Jakafi
Drug: 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.
Other Names:
  • Hormone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axillary temperature
Time Frame: 2 weeks
36<Axillary temperature<37.2, disease control; 37.2<Axillary temperature<38.2, disease partly control; Axillary temperature>38.2, disease active
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Research Institute of Pediatrics

Investigators

  • Principal Investigator: Yan Yue, MD, Capital Institute of Pediatrics, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

January 3, 2019

First Submitted That Met QC Criteria

January 5, 2019

First Posted (Actual)

January 8, 2019

Study Record Updates

Last Update Posted (Actual)

January 8, 2019

Last Update Submitted That Met QC Criteria

January 5, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLH-DR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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