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

Primary Purpose

Hemophagocytic Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PEG-rhG-CSF
rhG-CSF
Sponsored by
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemophagocytic Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Friendship Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PEG-rhG-CSF group

rhG-CSF group

Arm 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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Neutrophil dynamic changes
The dynamic changes of neutrophil count were observed after chemotherapy.
Efficacy evaluation of salvage therapy
Complete response (CR) and partial response (PR) rates.

Full Information

First Posted
July 24, 2020
Last Updated
August 3, 2020
Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Collaborators
Beijing Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04500886
Brief Title
Evaluate the Efficacy and Safety of PEG-rhG-CSF in Patients With Hemophagocytic Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Anticipated)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Collaborators
Beijing Friendship Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophagocytic Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEG-rhG-CSF group
Arm Type
Experimental
Arm 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
Arm Title
rhG-CSF group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
PEG-rhG-CSF
Intervention Description
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
Intervention Name(s)
rhG-CSF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Duration of grade IV neutropenia
Description
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 Outcome Measure Information:
Title
The recovery time of neutrophils after chemotherapy
Description
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.
Title
Neutrophil dynamic changes
Description
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.
Title
Efficacy evaluation of salvage therapy
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria： 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. Exclusion Criteria： 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhao Wang, PHD
Phone
86-1063139862
Email
catenny@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao Wang, PHD
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Friendship Hospital
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhao Wang, PHD
Phone
86-1063139862
Email
catenny@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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