Clinical Trial: Splenectomy as a Treatment for Patient With Relapsed Haemophagocytic Lymphohistiocytosis of Unknown Etiology
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title:
Brief Summary: To evaluate the clinical value of splenectomy as a treatment for relapsed haemophagocytic lymphohistiocytosis (HLH) in patient with unknown etiology.
Detailed Summary:
Sponsor: Beijing Friendship Hospital
Current Primary Outcome: Evaluation of treatment response [ Time Frame: Change from before and1,2,4,8,12 and 24 weeks after splenectomy ]
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%.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Survival [ Time Frame: from the time patients received splenectomy up to 24 months or December 2018 ]
- Adverse events that are related to treatment [ Time Frame: through study completion, an average of 2 years ]Adverse events including infection, bleeding and so on.
Original Secondary Outcome: Same as current
Information By: Beijing Friendship Hospital
Dates:
Date Received: August 6, 2016
Date Started: January 2015
Date Completion:
Last Updated: August 6, 2016
Last Verified: August 2016
