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Ruxolitinib as a Salvage Therapy for Hemophagocytic Lymphohistiocytosis

Phase 3
Conditions
Hemophagocytic Lymphohistiocytosis
Interventions
Registration Number
NCT04120090
Lead Sponsor
Beijing Friendship Hospital
Brief 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).

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
80
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 at least 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 RNA is negative;
  8. Both hepatitis B virus (HBV) surface antigen and HBV core antibody were negative. If any of the above is positive, peripheral blood hepatitis B virus DNA titer should be detected, and less than 1×103 copies/ml can enter the group;
  9. Informed consent.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Low doselow dose ruxolitinib-
High dosehigh dose ruxolitinib-
Primary Outcome Measures
NameTimeMethod
Response rate1 years

complete response (CR) and partial response (PR) rates

Progression Free Survival1 years

from date of inclusion to date of progression, relapse, or death from any cause Overall Survival

Secondary Outcome Measures
NameTimeMethod
Overall Survival1 years

from the date of inclusion to date of death, irrespective of cause Adverse Events

Adverse events1 year

Adverse events including myelosuppression, infection, bleeding and so on.

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University

🇨🇳

Beijing, Beijing, China

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