Hemophagocytic SyndromeNCT04500886
Evaluate the Efficacy and Safety of PEG-rhG-CSF in Patients With Hemophagocytic Syndrome
A study testing PEG-rhG-CSF and rhG-CSF in people with Hemophagocytic Syndrome, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemophagocytic Syndrome
- What is being tested?
- PEG-rhG-CSF and rhG-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Friendship Hospital
Beijing
Zhao Wang, PHD, 86-1063139862, catenny@hotmail.com
About this study
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
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
- Being tested
- PEG-rhG-CSF, rhG-CSF
- Medical subject headings
- Lymphohistiocytosis, Hemophagocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhG-CSFDrug
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-CSFDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: rhG-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Defined as days when the ANC<2.0×10^9/L occurs to the time when the ANC≥2.0×10^9/L.
Measured: From date of randomization until the date of the study completion，up to 1 year.
Neutrophil dynamic changes
The dynamic changes of neutrophil count were observed after chemotherapy.
Measured: From date of randomization until the date of the study completion，up to 1 year.
Efficacy evaluation of salvage therapy
Complete response (CR) and partial response (PR) rates.
Measured: From date of randomization until the date of the study completion，up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophagocytic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Friendship Hospital
- Responsible party
- Sponsor
- Investigators
- Zhao Wang, PHD, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500886
- Sponsor's protocol ID
- CSPC-JYL-HLH-01
- Status last verified
- Jul 2020
- First submitted
- 24 Jul 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04500886
- Acronym / sponsor ID
- CSPC-JYL-HLH-01
- Conditions
- Hemophagocytic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Friendship Hospital
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-rhG-CSF group | Experimental | Drug: PEG-rhG-CSFPatients 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 |
| rhG-CSF group | Active comparator | Drug: rhG-CSFPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG-rhG-CSFPEG-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. | Drug | PEG-rhG-CSF group |
| rhG-CSFrhG-CSF can increase the proliferation and differentiation of neutrophils from committed progenitor cells, induces maturation, and enhances the survival and function of mature neutrophils. | Drug | rhG-CSF group |
Primary outcome
Duration of grade IV neutropenia
Time frame: 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.
3 secondary outcomes
The recovery time of neutrophils after chemotherapy
Time frame: From date of randomization until the date of the study completion，up to 1 year.
Neutrophil dynamic changes
Time frame: From date of randomization until the date of the study completion，up to 1 year.
Efficacy evaluation of salvage therapy
Time frame: From date of randomization until the date of the study completion，up to 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhao Wang, PHD principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEG-rhG-CSF and rhG-CSF in people with Hemophagocytic Syndrome, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhao Wang, PHD (86-1063139862, catenny@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of grade IV neutropenia (time frame: From date of randomization until the date of the study completion，up to 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.