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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hemophagocytic Syndrome
• Intervention / Treatment: Drug: PEG-rhG-CSF; Drug: rhG-CSF

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEG-rhG-CSF group; Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®)24 hours after the end of chemotherapy, 6mg for patients with body weight ≥ 45kg and 3mg for patients with body weight less than 45kg, once per chemotherapy cycle	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.
Active Comparator: rhG-CSF group; Patients received subcutaneous injection of rhG-CSF 24 hours after the end of chemotherapy, 300ug for patients with body weight ≥45kg and 150ug for patients with body weight less than 45kg, Once a day for 3-5 days until the absolute count of neutrophils ≥2×109/L.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
• Collaborators: Beijing Friendship Hospital
• Investigators: Principal Investigator: Zhao Wang, PHD, Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Lymphatic Diseases; Disease; Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Syndrome; Lymphohistiocytosis, Hemophagocytic
• Other Study ID Numbers: CSPC-JYL-HLH-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No