Status:
UNKNOWN
Ruxolitinib as a Salvage Therapy for Hemophagocytic Lymphohistiocytosis
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
Hemophagocytic Lymphohistiocytosis
Eligibility:
All Genders
1-75 years
Phase:
PHASE3
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).
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04120090
Start Date
July 1 2019
End Date
July 1 2020
Last Update
October 29 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050