Splenectomy as a Treatment for Patient With Relapsed Haemophagocytic Lymphohistiocytosis of Unknown Etiology

Phase 2

• Conditions: Hemophagocytic Lymphohistiocytosis
• Interventions: Procedure: splenectomy

• Registration Number: NCT02862054
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

To evaluate the clinical value of splenectomy as a treatment for relapsed haemophagocytic lymphohistiocytosis (HLH) in patient with unknown etiology.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Status Verified: 2016-08
• Study First Submitted: 2016-08-06
• Study First Submitted QC: 2016-08-06
• Last Update Submitted: 2016-08-06
• Study First Posted: 2016-08-10
• Last Update Posted: 2016-08-10
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients were older than 14 years of age
2. Diagnosed as Hemophagocytic Lymphohistiocytosis (HLH) according to HLH-2004.
3. patients were excluded with infection, rheumatic and immunologic diseases, malignant tumors (especially lymphoma), and primary HLH.
4. Informed consent

Exclusion Criteria

1. Pregnancy or lactating Women
2. Active bleeding of the internal organs
3. Uncontrollable infection
4. Contraindication of splenectomy
5. Participate in other clinical research at the same time

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Splenectomy	splenectomy	Splenectomy as a treatment for patient with relapsed haemophagocytic lymphohistiocytosis of unknown etiology

Primary Outcome Measures

Name	Time	Method
Evaluation of treatment response	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%.

Secondary Outcome Measures

Name	Time	Method
Adverse events that are related to treatment	through study completion, an average of 2 years	Adverse events including infection, bleeding and so on.
Survival	from the time patients received splenectomy up to 24 months or December 2018

Trial Locations

Locations (1)

beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China