Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05137496
Other study ID # Ruxolitinib-steroids-MAS
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date June 1, 2022
Est. completion date June 1, 2024

Study information

Verified date March 2022
Source Beijing Friendship Hospital
Contact Yue Song
Phone 86-010-63139862
Email xueqifeng1992@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ruxolitinib
0.3mg/kg/d, iv.gtt, for at least 2 weeks
methylprednisolone
2mg/kg, d1-d5, gradually reduced, for at least 2 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Beijing Friendship Hospital

Outcome

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
See also
  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