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

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Hemophagocytic Syndrome

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: From date of randomization until the date of the study completion，up to 1 year.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: From date of randomization until the date of the study completion，up to 1 year.

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts