Hemophagocytic Lymphohistiocytosis Clinical Trial
Official title:
Clinical Study of Different Doses of Ruxolitinib as a Salvage Therapy for Refractory/Relapsed Hemophagocytic Lymphohistiocytosis
This study aimed to investigate the efficacy and safety of different doses of ruxolitinib as a salvage therapy for refractory/relapsed hemophagocytic lymphohistiocytosis(HLH).
Status | Recruiting |
Enrollment | 80 |
Est. completion date | July 1, 2020 |
Est. primary completion date | July 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 75 Years |
Eligibility |
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. 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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Friendship Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate | complete response (CR) and partial response (PR) rates | 1 years | |
Primary | Progression Free Survival | from date of inclusion to date of progression, relapse, or death from any cause Overall Survival | 1 years | |
Secondary | Overall Survival | from the date of inclusion to date of death, irrespective of cause Adverse Events | 1 years | |
Secondary | Adverse events | Adverse events including myelosuppression, infection, bleeding and so on. | 1 year |
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