Ruxolitinib and Methylprednisolone as a First-line Treatment for Macrophage Activation Syndrome

• Status: Not yet recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The present study was a single-center, prospective, non-comparative in which macrophage activation syndrome patients were selected as the main subjects to evaluate the effect and safety of Ruxolitinib and methylprednisolone regimens as the first-line therapy .

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

Details

• Lead Sponsor: Beijing Friendship Hospital
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

1. Meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria; patients were diagnosed with autoimmune disease associated HLH (Macrophage activation syndrome, MAS).

2. No HLH induction therapy was performed.

3. The expected survival time is more than 1 month.

4. 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；HBV copies less than 1E+03 copies/ml.

5. Total bilirubin ≤10 times the upper limit of normal; serum creatinine ≤1.5 times the normal value

6. The left ventricular ejection fraction (LVEF) was normal.

7. No uncontrollable infection.

8. Contraception for both male or female.

9. Informed consent obtained.

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.