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

• Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04500886
• Collaborator: Beijing Friendship Hospital (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 25
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemophagocytic Syndrome	Drug: PEG-rhG-CSF; Drug: rhG-CSF	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: 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
• Anticipated Study Start Date: Aug 1, 2020
• Anticipated Primary Completion Date: Aug 1, 2021
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Duration of grade IV neutropenia [From date of randomization until the date of the study completion，up to 1 year.]

   Defined as days when the ANC<0.5×10^9/L occurs to the time when the ANC≥0.5×10^9/L.

Secondary Outcome Measures

1. The recovery time of neutrophils after chemotherapy [From date of randomization until the date of the study completion，up to 1 year.]

   Defined as days when the ANC<2.0×10^9/L occurs to the time when the ANC≥2.0×10^9/L.

2. Neutrophil dynamic changes [From date of randomization until the date of the study completion，up to 1 year.]

   The dynamic changes of neutrophil count were observed after chemotherapy.

3. Efficacy evaluation of salvage therapy [From date of randomization until the date of the study completion，up to 1 year.]

   Complete response (CR) and partial response (PR) rates.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Friendship Hospital	Beijing		China

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Zhao Wang, PHD, Beijing Friendship Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04500886
• Other Study ID Numbers: CSPC-JYL-HLH-01
• First Posted: Aug 5, 2020
• Last Update Posted: Aug 5, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphohistiocytosis, Hemophagocytic; Syndrome

Study Results

No Results Posted as of Aug 5, 2020