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

Primary Purpose

Hemophagocytic Lymphohistiocytosis

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
splenectomy
Sponsored by
Beijing Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophagocytic Lymphohistiocytosis focused on measuring haemophagocytic lymphohistiocytosis, splenectomy, unknown etiology

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • beijing Friendship Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Splenectomy

Arm Description

Splenectomy as a treatment for patient with relapsed haemophagocytic lymphohistiocytosis of unknown etiology

Outcomes

Primary Outcome Measures

Evaluation of treatment response
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

Survival
Adverse events that are related to treatment
Adverse events including infection, bleeding and so on.

Full Information

First Posted
August 6, 2016
Last Updated
August 6, 2016
Sponsor
Beijing Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02862054
Brief Title
Splenectomy as a Treatment for Patient With Relapsed Haemophagocytic Lymphohistiocytosis of Unknown Etiology
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophagocytic Lymphohistiocytosis
Keywords
haemophagocytic lymphohistiocytosis, splenectomy, unknown etiology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Splenectomy
Arm Type
Experimental
Arm Description
Splenectomy as a treatment for patient with relapsed haemophagocytic lymphohistiocytosis of unknown etiology
Intervention Type
Procedure
Intervention Name(s)
splenectomy
Primary Outcome Measure Information:
Title
Evaluation of treatment response
Description
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%.
Time Frame
Change from before and1,2,4,8,12 and 24 weeks after splenectomy
Secondary Outcome Measure Information:
Title
Survival
Time Frame
from the time patients received splenectomy up to 24 months or December 2018
Title
Adverse events that are related to treatment
Description
Adverse events including infection, bleeding and so on.
Time Frame
through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients were older than 14 years of age Diagnosed as Hemophagocytic Lymphohistiocytosis (HLH) according to HLH-2004. patients were excluded with infection, rheumatic and immunologic diseases, malignant tumors (especially lymphoma), and primary HLH. Informed consent Exclusion Criteria: Pregnancy or lactating Women Active bleeding of the internal organs Uncontrollable infection Contraindication of splenectomy Participate in other clinical research at the same time
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jingshi wang, M.M.
Phone
86-13520280731
Email
wangjingshi987@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhao wang
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jingshi wang, M.M.
Phone
86-13520280731
Email
wangjingshi987@sina.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
25512183
Citation
Jing-Shi W, Yi-Ni W, Lin W, Zhao W. Splenectomy as a treatment for adults with relapsed hemophagocytic lymphohistiocytosis of unknown cause. Ann Hematol. 2015 May;94(5):753-60. doi: 10.1007/s00277-014-2276-9. Epub 2014 Dec 16.
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Splenectomy as a Treatment for Patient With Relapsed Haemophagocytic Lymphohistiocytosis of Unknown Etiology

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