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

CSPC Pharmaceutical Group

Status: Unknown

Conditions: Hemophagocytic Syndrome

Treatments: Drug: PEG-rhG-CSF; Drug: rhG-CSF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04500886

CSPC-JYL-HLH-01

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

PEG-rhG-CSF group

Experimental group

Description:

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

Treatment:

Drug: PEG-rhG-CSF

rhG-CSF group

Active Comparator group

Description:

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.

Treatment:

Drug: rhG-CSF