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

NCT04500886 | Unknown

• 1 other identifier: CSPC-JYL-HLH-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The recovery time of neutrophils after chemotherapy

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

• Neutrophil dynamic changes

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

• Efficacy evaluation of salvage therapy

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

Study Arms (2)

PEG-rhG-CSF group

EXPERIMENTAL

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

rhG-CSF group

ACTIVE COMPARATOR

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

Interventions

PEG-rhG-CSF 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.

PEG-rhG-CSF group

rhG-CSF 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.

rhG-CSF group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, ≤ 70 years old;
• Patients with hemophagocytic syndrome diagnosed by HLH-2004 diagnostic criteria;
• Patients who plan to receive rescue treatment or maintenance treatment;
• The expected survival time is more than 1 month;
• Patients sign informed consent form.

You may not qualify if:

• Patients who have received bone marrow or hematopoietic stem cell transplantation in the past 3 months;
• Patients with brain metastases;
• Patients who are allergic to this product or other biological products derived from genetic engineering E. coli;
• People with mental or nervous system disorders who cannot cooperate;
• Pregnant or lactating female patients; women who refuse to accept contraceptive measures ;
• Researchers determine unsuited to participate in this trial.

Sponsors & Collaborators

• CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.: lead
• Beijing Friendship Hospital: collaborator

Study Sites (1)

Beijing Friendship Hospital

Beijing, China

Location

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Zhao Wang, PHD

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Wang, PHD

CONTACT

86-1063139862; catenny@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: August 5, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2022
• Last Updated: August 5, 2020

Record last verified: 2020-07

Locations

CN (1)