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

NCT ID: NCT05137496

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-06-01

Brief 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 .

Conditions

Macrophage Activation Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ruxolitinib+methylprednisolone

Ruxolitinib and methylprednisolone administered as the first-line therapy

Group Type: EXPERIMENTAL

Ruxolitinib

Intervention Type: DRUG

0.3mg/kg/d, iv.gtt, for at least 2 weeks

methylprednisolone

Intervention Type: DRUG

2mg/kg, d1-d5, gradually reduced, for at least 2 weeks

Interventions

Ruxolitinib

0.3mg/kg/d, iv.gtt, for at least 2 weeks

Intervention Type: DRUG

methylprednisolone

2mg/kg, d1-d5, gradually reduced, for at least 2 weeks

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Wang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Yue Song

Role: CONTACT

xueqifeng1992@163.com

86-010-63139862

Other Identifiers

Ruxolitinib-steroids-MAS

Identifier Type: -

Identifier Source: org_study_id