Ruxolitinib as a Salvage Therapy for Hemophagocytic Lymphohistiocytosis

• Status: Unknown status
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Friendship Hospital

Criteria

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.