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

NCT02862054 | Unknown Phase 2 DMC

• 1 other identifier: Splenectomy-HLH
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemophagocytic Lymphohistiocytosis

Keywords

haemophagocytic lymphohistiocytosis; splenectomy; unknown etiology

Outcome Measures

Primary Outcomes (1)

• 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%.

  Change from before and1,2,4,8,12 and 24 weeks after splenectomy

Secondary Outcomes (2)

• Survival

  from the time patients received splenectomy up to 24 months or December 2018

• Adverse events that are related to treatment

  through study completion, an average of 2 years

Study Arms (1)

Splenectomy

EXPERIMENTAL

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

Procedure: splenectomy

Interventions

splenectomy PROCEDURE

Splenectomy

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or lactating Women
• Active bleeding of the internal organs
• Uncontrollable infection
• Contraindication of splenectomy
• Participate in other clinical research at the same time

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 25512183 BACKGROUND

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic

Interventions

Splenectomy

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• zhao wang

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jingshi wang, M.M.

CONTACT

86-13520280731; wangjingshi987@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 6, 2016
• First Posted: August 10, 2016
• Study Start: January 1, 2015
• Primary Completion: December 1, 2017
• Last Updated: August 10, 2016

Record last verified: 2016-08

Locations

CN (1)