UnknownPhase 3

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

40 participantsStarted 2022-06-01

Plain-language 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 .

Who can participate

Age range1 Year – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria; patients were diagnosed with autoimmune disease associated HLH (Macrophage activation syndrome, MAS).
✓. No HLH induction therapy was performed.
✓. The expected survival time is more than 1 month.
✓. 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.
✓. Total bilirubin ≤10 times the upper limit of normal; serum creatinine ≤1.5 times the normal value
✓. The left ventricular ejection fraction (LVEF) was normal.
✓. No uncontrollable infection.
✓. Contraception for both male or female.

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.

What they're measuring

Response rate

Timeframe: Change from before and 2,4,6 and 8 weeks after initiating Ruxolitinib combined with methylprednisolone therapy

Progression Free Survival

Timeframe: 2 years

Adverse events

Timeframe: 2 years

Trial details

NCT IDNCT05137496

SponsorBeijing Friendship Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-01

Contact for this trial

Yue Song

86-010-63139862 xueqifeng1992@163.com

View on ClinicalTrials.gov More Macrophage Activation Syndrome trials