Ruxolitinib as a Salvage Therapy for Hemophagocytic Lymphohistiocytosis

Last updated: October 27, 2019
Sponsor: Beijing Friendship Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Bone Marrow Disorder

Histiocytoma

White Cell Disorders

Treatment

N/A

Clinical Study ID

NCT04120090
Ruxolitinib-HLH
  • Ages 1-75
  • All Genders

Study Summary

This study aimed to investigate the efficacy and safety of different doses of ruxolitinib as a salvage therapy for refractory/relapsed hemophagocytic lymphohistiocytosis(HLH).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria;

  2. treated with HLH-94 no less than 2 weeks before enrollment and did not achieve atleast PR; or relapsed patients after remission;

  3. Life expectancy exceeds 1 month;

  4. Age≥1 year old and ≤75 years old, gender is not limited;

  5. Before the start of the study, total bilirubin ≤ 10 times the upper limit of normal;serum creatinine ≤ 1.5 times normal;

  6. Serum human immunodeficiency virus(HIV) antigen or antibody negative;

  7. Hepatitis C virus (HCV) antibody is negative, or HCV antibody is positive, but HCV RNAis negative;

  8. Both hepatitis B virus (HBV) surface antigen and HBV core antibody were negative. Ifany of the above is positive, peripheral blood hepatitis B virus DNA titer should bedetected, and less than 1×103 copies/ml can enter the group;

  9. Informed consent.

Exclusion

Exclusion Criteria:

  1. Pregnancy or lactating Women;

  2. Allergic to ruxolitinib;

  3. Active bleeding of the internal organs;

  4. uncontrollable infection;

  5. Serious mental illness;

  6. Non-melanoma skin cancer history;

  7. Patients unable to comply during the trial and/or follow-up phase;

  8. Participate in other clinical research at the same time.

Study Design

Total Participants: 80
Study Start date:
July 01, 2019
Estimated Completion Date:
July 01, 2020

Connect with a study center

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Active - Recruiting

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