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
- meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria;
- treated with HLH-94 no less than 2 weeks before enrollment and did not achieve at least PR; or relapsed patients after remission;
- Life expectancy exceeds 1 month;
- Age≥1 year old and ≤75 years old, gender is not limited;
- Before the start of the study, total bilirubin ≤ 10 times the upper limit of normal; serum creatinine ≤ 1.5 times normal;
- Serum human immunodeficiency virus(HIV) antigen or antibody negative;
- Hepatitis C virus (HCV) antibody is negative, or HCV antibody is positive, but HCV RNA is negative;
- 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;
- Informed consent.
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Exclusion Criteria
- Pregnancy or lactating Women;
- Allergic to ruxolitinib;
- Active bleeding of the internal organs;
- uncontrollable infection;
- Serious mental illness;
- Non-melanoma skin cancer history;
- Patients unable to comply during the trial and/or follow-up phase;
- Participate in other clinical research at the same time.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low dose low dose ruxolitinib - High dose high dose ruxolitinib -
- Primary Outcome Measures
Name Time Method Response rate 1 years complete response (CR) and partial response (PR) rates
Progression Free Survival 1 years from date of inclusion to date of progression, relapse, or death from any cause Overall Survival
- Secondary Outcome Measures
Name Time Method Overall Survival 1 years from the date of inclusion to date of death, irrespective of cause Adverse Events
Adverse events 1 year Adverse events including myelosuppression, infection, bleeding and so on.
Trial Locations
- Locations (1)
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China