Macrophage Activation Syndrome Clinical Trial
Official title:
A Single-center, Prospective, Non-comparative Clinical Trial of Ruxolitinib and Methylprednisolone as a First-line Treatment for Macrophage Activation Syndrome
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 .
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | June 1, 2024 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Beijing Friendship Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate | A complete response was defined as normalization of all of the quantifiable symptoms and laboratory markers of HLH, including levels of sCD25, ferritin, and triglyceride; hemoglobin; neutrophil counts; platelet counts; and alanine aminotransferase (ALT).
A partial response was defined as at least a 25% improvement in 2 or more quantifiable symptoms and laboratory markers as follows: sCD25 response was>1.5-fold decreased; ferritin and triglyceride decreased at least 25%; for patients with an initial neutrophil count of<0.5 ×109/L, a response was defined as an increase by at least 100% to>0.5× 109/L; for patients with a neutrophil count of 0.5 to 2.0 × 109/L, an increase by at least 100% to >2.0 × 109/L was considered a response; and for patients with ALT >400 U/L, response was defined as an ALT decrease of at least 50%. |
Change from before and 2,4,6 and 8 weeks after initiating Ruxolitinib combined with methylprednisolone therapy | |
Primary | Progression Free Survival | from date of inclusion to date of progression, relapse, or death from any cause | 2 years | |
Primary | Adverse events | Adverse events including myelosuppression, infection, hemorrhage | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06405152 -
Assessment of Macrophage Activation syndromE in STill's Disease
|
||
Not yet recruiting |
NCT03721809 -
Characterization of the Inflammatory Profile of Patients With Macrophage Activation Syndrome Secondary to Bacterial Sepsis
|
N/A | |
Active, not recruiting |
NCT02780583 -
Treatment of Macrophage Activation Syndrome (MAS) With Anakinra
|
Phase 1 | |
Active, not recruiting |
NCT01966367 -
CD34+ (Non-Malignant) Stem Cell Selection for Patients Receiving Allogeneic Stem Cell Transplantation
|
Phase 1/Phase 2 | |
Enrolling by invitation |
NCT01095146 -
New Candidate Criteria for Diagnosis of Macrophage Activation Syndrome
|
N/A | |
Recruiting |
NCT06339177 -
Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study
|
||
Recruiting |
NCT02569463 -
Low-dose IL-2 ( Interleukin-2) Treatment in Macrophage Activation Syndrome(MAS)
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03827343 -
Retrospective Study of Immunotherapy Related Toxicities and Factors Impacting Outcomes in Children and Adults With Cancer
|
||
Recruiting |
NCT05611710 -
Anakinra in Dengue With Hyperinflammation ( AnaDen )
|
Phase 2 | |
Completed |
NCT03311854 -
A Study to Investigate the Safety and Efficacy of Emapalumab, an Anti-IFN-gamma mAb in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH)
|
Phase 2 | |
Recruiting |
NCT05001737 -
Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE
|
Phase 3 | |
Completed |
NCT03332225 -
A Trial of Validation and Restoration of Immune Dysfunction in Severe Infections and Sepsis
|
Phase 2 | |
Completed |
NCT04339712 -
Personalised Immunotherapy for SARS-CoV-2 (COVID-19) Associated With Organ Dysfunction
|
Phase 2 |