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Ruxolitinib Combined With Dexamethasone for HLH

Sponsor
Capital Research Institute of Pediatrics (Other)
Overall Status
Unknown status
CT.gov ID
NCT03795909
Collaborator
(none)
50
Enrollment
2
Locations
2
Arms
60
Anticipated Duration (Months)
25
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Ruxolitinib Combined With Dexamethasone for Pediatric Refractory and Secondary Hemophagocytic Lymphohistiocytosis
Actual Study Start Date :
Mar 1, 2017
Anticipated Primary Completion Date :
Mar 1, 2020
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Severity of disease [2 weeks]

      Serum ferritin>2000ng/ml, disease actvie; serum ferritin<2000ng/ml, disease control;

    Secondary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Secondary and refractory HLH.
    Exclusion Criteria:
    • Family HLH.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yan Yue Beijing Chaoyang District China 100020
    2 Yan Yue Beijing China

    Sponsors and Collaborators

    • Capital Research Institute of Pediatrics

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yan Yue, Principal Investigator, Capital Research Institute of Pediatrics
    ClinicalTrials.gov Identifier:
    NCT03795909
    Other Study ID Numbers:
    • HLH-DR
    First Posted:
    Jan 8, 2019
    Last Update Posted:
    Jan 8, 2019
    Last Verified:
    Jan 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphohistiocytosis, Hemophagocytic
    Dexamethasone

    Study Results

    No Results Posted as of Jan 8, 2019