Non Hodgkin's LymphomaNCT04497688
Evaluate the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma
A study testing PEG-rhG-CSF in people with Non Hodgkin's Lymphoma, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The main treatments for non-Hodgkin's lymphoma are surgery, radiotherapy, chemotherapy, and bone marrow transplantation. Neutropenia is the most common and serious complication of most chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin's Lymphoma
- What is being tested?
- PEG-rhG-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Oct 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, gender is not limited;
- Patients with lymphoma diagnosed by histopathology or cytology;
- Patients requiring multi-cycle chemotherapy;
- Planned chemotherapy regimen FN risk ≥ 20 % , or 10% <FN risk < 20% with high risk factors ; According to the judgment of the investigator, there is a risk of FN occurrence if G-CSF support is not accepted, PEG-rhG-CSF should be used prophylactically from the first cycle;
- Physical status (KPS) score ≥ 70 points;
- Expected Survival period of more than 3 months;
Show all 10Show fewer
- Normal bone marrow hematopoietic function (ANC ≥1.5×10^9/L, PLT≥80×10^9/L, Hb≥75g/L, WBC≥3.0×10^9/L);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5 times the upper limit of normal value, or≤5 times the upper limit of normal value when there is liver metastasis; total bilirubin (TBIL)≤2.5 times the upper limit of normal value; serum creatinine (Cr)≤2 times the upper limit of normal value;
- Female patients of childbearing age must be negative in urine pregnancy test before treatment;
- The testers (or their legal representatives/guardians) must sign an informed consent form.
Who cannot join
- Lymphoma central involvement;
- Hematopoietic stem cell transplantation or organ transplantation;
- Local or systemic infection without adequate control;
- Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction;
- Those who used other test drugs of the same kind or accepted other clinical trials within 4 weeks before enrollmen；
- Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
Show all 9Show fewer
- Severe mental illness, affecting informed consent and/or adverse reaction expression or observation;
- 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, 1 recruiting
- Recruiting
The fourth hospital of Hebei Medical University
Shijiazhuang, Hebei, 050019
Lihong Liu, PHD, 86-13831177920, 13831177920@163.com
About this study
Official title: A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of PEG-rhG-CSF(Jinyouli®) in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma
The main treatments for non-Hodgkin's lymphoma are surgery, radiotherapy, chemotherapy, and bone marrow transplantation. Neutropenia is the most common and serious complication of most chemotherapy. This study is a multi-center, open-label, single-arm clinical study to evaluate the efficacy and safety of jinyouli in preventing neutropenia in patients with non Hodgkin's lymphoma after chemotherapy.
- Conditions
- Non Hodgkin's Lymphoma
- Being tested
- PEG-rhG-CSF
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhG-CSFDrug
Patients received a single dose of PEG-rhG-CSF per cycle. The chemotherapy regimen must meet the interval between two chemotherapy sessions at least 12 days.
| Study group | Role | What they receive |
|---|---|---|
| PEG-rhG-CSF group | Experimental | Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®) 48 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of grade Ⅲ/Ⅳ neutropenia
Grade Ⅲ neutropenia is defined as ANC≥0.5×10^9/L, and <1×10^9/L; Grade Ⅳ neutropenia is defined as ANC<0.5×10^9/L
Measured: From date of randomization until the date of the study completion，up to 24 weeks
Secondary outcomes (3)
Incidence of febrile neutropenia (FN)
A single oral temperature is 38.3℃ or ≥38℃ for more than 1 h, and the absolute value of neutrophils is less than 0.5×10^9/L or the absolute value of neutrophils is less than 1.0×10^9/L but it is expected to drop to less than 0.5×10^9/L within 48 hours
Measured: From date of randomization until the date of the study completion，up to 24 weeks
Antibiotic use rate
Antibiotic use rate during the treatment cycle
Measured: From date of randomization until the date of the study completion，up to 24 weeks
Incidence of dose adjustment of chemotherapy or delay of chemotherapy
Dose adjustment is defined as the reduction of planned dose of chemotherapy; Chemotherapy delay is defined as the delay in starting the next planned chemotherapy for more than 3 days.
Measured: From date of randomization until the date of the study completion，up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start1 Jan 2019
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin's LymphomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hebei Medical University Fourth Hospital
- Responsible party
- Sponsor
- Investigators
- Lihong Liu, PHD, Principal investigator, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497688
- Sponsor's protocol ID
- CSPC -JYL-NHL-03
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2020
- Last updated
- 4 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 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of PEG-rhG-CSF(Jinyouli®) in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT04497688
- Acronym / sponsor ID
- CSPC -JYL-NHL-03
- Conditions
- Non Hodgkin's Lymphoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hebei Medical University Fourth Hospital
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 4 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.
The main treatments for non-Hodgkin's lymphoma are surgery, radiotherapy, chemotherapy, and bone marrow transplantation. Neutropenia is the most common and serious complication of most chemotherapy. This study is a multi-center, open-label, single-arm clinical study to evaluate the efficacy and safety of jinyouli in preventing neutropenia in patients with non Hodgkin's lymphoma after chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEG-rhG-CSF group | Experimental | Drug: PEG-rhG-CSFPatients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®) 48 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years, gender is not limited;
- Patients with lymphoma diagnosed by histopathology or cytology;
- Patients requiring multi-cycle chemotherapy;
- Planned chemotherapy regimen FN risk ≥ 20 % , or 10% <FN risk < 20% with high risk factors ; According to the judgment of the investigator, there is a risk of FN occurrence if G-CSF support is not accepted, PEG-rhG-CSF should be used prophylactically from the first cycle;
- Physical status (KPS) score ≥ 70 points;
Key exclusion criteria (9 listed)
- Lymphoma central involvement;
- Hematopoietic stem cell transplantation or organ transplantation;
- Local or systemic infection without adequate control;
- Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction;
- Those who used other test drugs of the same kind or accepted other clinical trials within 4 weeks before enrollmen；
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-CSFPatients received a single dose of PEG-rhG-CSF per cycle. The chemotherapy regimen must meet the interval between two chemotherapy sessions at least 12 days. | Drug | PEG-rhG-CSF group |
Primary outcome
The incidence of grade Ⅲ/Ⅳ neutropenia
Time frame: From date of randomization until the date of the study completion，up to 24 weeks
Grade Ⅲ neutropenia is defined as ANC≥0.5×10^9/L, and <1×10^9/L; Grade Ⅳ neutropenia is defined as ANC<0.5×10^9/L
3 secondary outcomes
Incidence of febrile neutropenia (FN)
Time frame: From date of randomization until the date of the study completion，up to 24 weeks
Antibiotic use rate
Time frame: From date of randomization until the date of the study completion，up to 24 weeks
Incidence of dose adjustment of chemotherapy or delay of chemotherapy
Time frame: From date of randomization until the date of the study completion，up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
Related trials for Non Hodgkin's Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma
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.
Lihong Liu, PHD principal investigator
Hebei Medical University Fourth 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 in people with Non Hodgkin's Lymphoma, 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 10 inclusion and 9 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 4 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 Lihong Liu, PHD (86-13831177920, 13831177920@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of grade Ⅲ/Ⅳ neutropenia (time frame: From date of randomization until the date of the study completion，up to 24 weeks). 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 4 Aug 2020.