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

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ClinicalTrials.gov Identifier: NCT02862054
Recruitment Status : Recruiting
First Posted : August 10, 2016
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Zhao Wang, 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.

Condition or disease Intervention/treatment Phase
Hemophagocytic Lymphohistiocytosis Procedure: splenectomy Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2015
Estimated Primary Completion Date : December 2017


Arm Intervention/treatment
Experimental: Splenectomy
Splenectomy as a treatment for patient with relapsed haemophagocytic lymphohistiocytosis of unknown etiology
Procedure: splenectomy



Primary Outcome Measures :
  1. 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%.



Secondary Outcome Measures :
  1. Survival [ Time Frame: from the time patients received splenectomy up to 24 months or December 2018 ]
  2. 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.



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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862054


Contacts
Contact: jingshi wang, M.M. 86-13520280731 wangjingshi987@sina.com

Locations
China, Beijing
beijing Friendship Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: jingshi wang, M.M.    86-13520280731    wangjingshi987@sina.com   
Sponsors and Collaborators
Beijing Friendship Hospital
Investigators
Principal Investigator: zhao wang Beijing Friendship Hospital

Publications:
Responsible Party: Zhao Wang, Doctor, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT02862054     History of Changes
Other Study ID Numbers: Splenectomy-HLH
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016

Keywords provided by Zhao Wang, Beijing Friendship Hospital:
haemophagocytic lymphohistiocytosis
splenectomy
unknown etiology

Additional relevant MeSH terms:
Lymphohistiocytosis, Hemophagocytic
Histiocytosis, Non-Langerhans-Cell
Histiocytosis
Lymphatic Diseases