Evaluate the Efficacy and Safety of PEG-rhG-CSF in Patients With Hemophagocytic Syndrome

Hemophagocytic Syndrome Clinical Trial

Official title:

A Single-center, Open-label, Controlled Clinical Study to Evaluate the Efficacy and Safety of Jinyouli®(PEG-rhG-CSF) for the Recovery of Neutropenia After Chemotherapy in Patients With Hemophagocytic Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04500886
• Other study ID #: CSPC-JYL-HLH-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: July 2020
• Source: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
• Contact: Zhao Wang, PHD
• Phone: 86-1063139862
• Email: catenny[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hemophagocytic syndrome (HPS), also known as hemophagocytic lymphohistiocytosis (HLH), is an immune mediated life-threatening disease. There is no uniform recommendation for salvage treatment of HLH. Based on the results of current clinical trials, the marketing situation of the drug in China, and the use requirements of pegylated recombinant human granulocyte stimulating factor(PEG-rhG-CSF), this study was conducted in patients who received the DEP rescue therapy or dexamethasone combined with VP-16 maintenance therapy. The aim of this study was to evaluate the efficacy and safety of PEG-rhG-CSF(Jinyouli®) for the recovery of neutropenia after chemotherapy in patients with hemophagocytic syndrome.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 1, 2022
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

1. Age = 18 years old, = 70 years old;

2. Patients with hemophagocytic syndrome diagnosed by HLH-2004 diagnostic criteria;

3. Patients who plan to receive rescue treatment or maintenance treatment;

4. The expected survival time is more than 1 month;

5. Patients sign informed consent form.

Exclusion Criteria:

1. Patients who have received bone marrow or hematopoietic stem cell transplantation in the past 3 months;

2. Patients with brain metastases;

3. Patients who are allergic to this product or other biological products derived from genetic engineering E. coli;

4. People with mental or nervous system disorders who cannot cooperate;

5. Pregnant or lactating female patients; women who refuse to accept contraceptive measures ;

6. Researchers determine unsuited to participate in this trial.

Related Conditions & MeSH terms

• Hemophagocytic Syndrome
• Lymphohistiocytosis, Hemophagocytic
• Syndrome

Intervention

Drug:
• PEG-rhG-CSF
PEG-rhG-CSF is a sustained-duration form of rhG-CSF, a recombinant methionyl form of human granulocyte colony-stimulating factor (G-CSF), similar to rhG-CSF, PEG-rhG-CSF increases the proliferation and differentiation of neutrophils from committed progenitor cells, induces maturation, and enhances the survival and function of mature neutrophils, resulting in dose-dependent increases in neutrophils.
• rhG-CSF
rhG-CSF can increase the proliferation and differentiation of neutrophils from committed progenitor cells, induces maturation, and enhances the survival and function of mature neutrophils.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.	Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of grade IV neutropenia	Defined as days when the ANC<0.5×10^9/L occurs to the time when the ANC=0.5×10^9/L.	From date of randomization until the date of the study completion,up to 1 year.
Secondary	The recovery time of neutrophils after chemotherapy	Defined as days when the ANC<2.0×10^9/L occurs to the time when the ANC=2.0×10^9/L.	From date of randomization until the date of the study completion,up to 1 year.
Secondary	Neutrophil dynamic changes	The dynamic changes of neutrophil count were observed after chemotherapy.	From date of randomization until the date of the study completion,up to 1 year.
Secondary	Efficacy evaluation of salvage therapy	Complete response (CR) and partial response (PR) rates.	From date of randomization until the date of the study completion,up to 1 year.