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

NCT ID: NCT04500886

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-09-01

Brief 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.

Conditions

Hemophagocytic Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

PEG-rhG-CSF

Intervention Type: DRUG

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 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.

Group Type: ACTIVE_COMPARATOR

rhG-CSF

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: collaborator

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhao Wang, PHD

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

Beijing Friendship Hospital

Beijing, , China

Countries

China

Central Contacts

Zhao Wang, PHD

Role: CONTACT

catenny@hotmail.com

86-1063139862

Facility Contacts

Zhao Wang, PHD

Role: primary

catenny@hotmail.com

86-1063139862

Other Identifiers

CSPC-JYL-HLH-01

Identifier Type: -

Identifier Source: org_study_id