Elderly Lymphoma PatientsNCT03870412
Evaluation of the Application of PEGylated Recombinant Human Granulocyte Stimulating Factor Injection (PEG-rhG-CSF) in Chemotherapy of Elderly Lymphoma Patients
A study testing PEG-rhG-CSF in people with Elderly Lymphoma Patients, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
A multicenter, open, one-arm clinical study evaluated the efficacy and safety of Jinyouli in preventing neutropenia after chemotherapy in elderly lymphoma patients who met the criteria for admission. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly Lymphoma Patients
- 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
- 485 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2019to 22 Aug 2021
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- (1) Age ≥ 65 years, gender is not limited;
- (2) Patients with lymphoma diagnosed by histopathology or cytology;
- (3) Patients requiring multi-cycle chemotherapy;
- (4) Planned chemotherapy regimen FN risk ≥ 20 % (see Annex I), or 10% <FN risk < 20% (see Annex II) with high risk factors for at least one FN;
- (5) Physical status (KPS) score ≥ 70 points;
- (6) Expected Survival period of more than 3 months;
- (7) normal bone marrow hematopoietic function (ANC ≥1.5×109/L, PLT≥100×109/L, Hb≥80g/L, WBC≥3.0×109/L);
- (8) The testers (or their legal representatives/guardians) must sign an informed consent form.
Who cannot join
- (1) Lymphoma central involvement;
- (2) Hematopoietic stem cell transplantation or organ transplantation;
- (3) Insufficient local or systemic infection;
- (4) Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction;
- (5) Liver function tests total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) are >2.5 times the upper limit of normal, if the above indicators are >5 times due to liver metastasis Upper limit of normal value; renal function test: serum creatinine (Cr) > 2 times the upper limit of normal;
- (6) allergic to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
- (7) Severe mental illness, affecting informed consent and/or adverse reaction expression or observation;
- (8) The investigator judges patients who are not suitable for participation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Hospital
Guangzhou
Huiqiang Huang, 13808885154, huanghq@sysucc.org.cn
About this study
Official title: Multi-center, Open, One-arm Clinical Study Evaluating the Efficacy and Safety of Pegylated Recombinant Human Granulocyte-stimulating Factor Injection (PEG-rhG-CSF) in Preventing Neutropenia in Elderly Patients With Lymphoma After Chemotherapy
A multicenter, open, one-arm clinical study evaluated the efficacy and safety of Jinyouli in preventing neutropenia after chemotherapy in elderly lymphoma patients who met the criteria for admission. Chemotherapy regimen: The investigator selected according to the specific condition the corresponding standard chemotherapy regimen, the chemotherapy regimen used, FN risk ≥ 20%, or 10% < FN risk < 20% with at least one high risk factor for FN, from the first cycle of chemotherapy, 24-72 after chemotherapy hour subcutaneous injection of Jinyouli.
- Conditions
- Elderly Lymphoma Patients
- Being tested
- PEG-rhG-CSF
- Keywords
- PEG-rhG-CSF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhG-CSFDrug
The test drug PEG-rhG-CSF was administered prophylactically to elderly lymphoma patients who met the inclusion/exclusion criteria 24-72 hours after chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| PEG-rhG-CSF | Experimental | Jin Youli(PEG-rhG-CSF):From the first cycle of chemotherapy, Jin Youli(PEG-rhG-CSF) was injected subcutaneously 24-72 hours after the end of chemotherapy, 6 mg was given to patients with body weight ≥45 kg, and 3 mg was given for body weight <45 kg. Inject once every chemotherapy cycle. Receives: Drug: PEG-rhG-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of febrile neutropenia in cycles 1 to 6
The body temperature standard for neutropenic fever is sputum temperature; febrile neutropenia is defined as ANC < 0.5*109 / L and sputum temperature> 38.0 ° C.
Measured: through 1-6 cycles of PEG-rhG-CSF,an average of 6 month
Secondary outcomes (4)
The incidence of grade IV neutropenia in the first to sixth cycles of PEG-rhG-CSF.
The incidence of grade IV neutropenia in the first to sixth cycles of PEG-rhG-CSF.
Measured: through 1-6 cycles of PEG-rhG-CSF,an average of 6 month
Incidence of dose adjustment of chemotherapy drugs in each chemotherapy cycle
Incidence of dose adjustment of chemotherapy drugs in each chemotherapy cycle
Measured: through 1-6 cycles of PEG-rhG-CSF,an average of 6 month
Incidence of chemotherapy delays in each chemotherapy cycle
Incidence of chemotherapy delays in each chemotherapy cycle
Measured: through 1-6 cycles of PEG-rhG-CSF,an average of 6 month
The proportion of patients receiving antibiotics during the entire chemotherapy period.
The proportion of patients receiving antibiotics during the entire chemotherapy period.
Measured: through 1-6 cycles of PEG-rhG-CSF,an average of 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start22 Feb 2019
- Primary completion22 Mar 2021 (estimated)
- Study completion22 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly Lymphoma PatientsStudies 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
- 485 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huiqiang Huang, Principal investigator, Sun Yat-sen University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870412
- Sponsor's protocol ID
- CSPC-JYL-LY-03
- Status last verified
- Feb 2019
- First submitted
- 8 Mar 2019
- Last updated
- 14 Mar 2019
- 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 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Open, One-arm Clinical Study Evaluating the Efficacy and Safety of Pegylated Recombinant Human Granulocyte-stimulating Factor Injection (PEG-rhG-CSF) in Preventing Neutropenia in Elderly Patients With Lymphoma After Chemotherapy
- ClinicalTrials.gov ID
- NCT03870412
- Acronym / sponsor ID
- CSPC-JYL-LY-03
- Conditions
- Elderly Lymphoma Patients
- Keywords
- PEG-rhG-CSF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 485 participants (estimated)
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 22 Mar 2021 (estimated)
- Study completion
- 22 Aug 2021 (estimated)
- First posted
- 12 Mar 2019 (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.
A multicenter, open, one-arm clinical study evaluated the efficacy and safety of Jinyouli in preventing neutropenia after chemotherapy in elderly lymphoma patients who met the criteria for admission. Chemotherapy regimen: The investigator selected according to the specific condition the corresponding standard chemotherapy regimen, the chemotherapy regimen used, FN risk ≥ 20%, or 10% < FN risk < 20% with at least one high risk factor for FN, from the first cycle of chemotherapy, 24-72 after chemotherapy hour subcutaneous injection of Jinyouli.
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 | Experimental | Drug: PEG-rhG-CSFJin Youli(PEG-rhG-CSF):From the first cycle of chemotherapy, Jin Youli(PEG-rhG-CSF) was injected subcutaneously 24-72 hours after the end of chemotherapy, 6 mg was given to patients with body weight ≥45 kg, and 3 mg was given for body weight <45 kg. Inject once every chemotherapy cycle. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- (1) Age ≥ 65 years, gender is not limited;
- (2) Patients with lymphoma diagnosed by histopathology or cytology;
- (3) Patients requiring multi-cycle chemotherapy;
- (4) Planned chemotherapy regimen FN risk ≥ 20 % (see Annex I), or 10% <FN risk < 20% (see Annex II) with high risk factors for at least one FN;
- (5) Physical status (KPS) score ≥ 70 points;
Key exclusion criteria (8 listed)
- (1) Lymphoma central involvement;
- (2) Hematopoietic stem cell transplantation or organ transplantation;
- (3) Insufficient local or systemic infection;
- (4) Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction;
- (5) Liver function tests total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) are >2.5 times the upper limit of normal, if the above indicators are >5 times due to liver metastasis Upper limit of normal value; renal function test: serum creatinine (Cr) > 2 times the upper limit of normal;
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-CSFThe test drug PEG-rhG-CSF was administered prophylactically to elderly lymphoma patients who met the inclusion/exclusion criteria 24-72 hours after chemotherapy. | Drug | PEG-rhG-CSF |
Primary outcome
Incidence of febrile neutropenia in cycles 1 to 6
Time frame: through 1-6 cycles of PEG-rhG-CSF,an average of 6 month
The body temperature standard for neutropenic fever is sputum temperature; febrile neutropenia is defined as ANC < 0.5*109 / L and sputum temperature> 38.0 ° C.
4 secondary outcomes
The incidence of grade IV neutropenia in the first to sixth cycles of PEG-rhG-CSF.
Time frame: through 1-6 cycles of PEG-rhG-CSF,an average of 6 month
Incidence of dose adjustment of chemotherapy drugs in each chemotherapy cycle
Time frame: through 1-6 cycles of PEG-rhG-CSF,an average of 6 month
Incidence of chemotherapy delays in each chemotherapy cycle
Time frame: through 1-6 cycles of PEG-rhG-CSF,an average of 6 month
The proportion of patients receiving antibiotics during the entire chemotherapy period.
Time frame: through 1-6 cycles of PEG-rhG-CSF,an average of 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
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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.
Huiqiang Huang principal investigator
Sun Yat-sen University Cancer 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 Elderly Lymphoma Patients, 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 8 inclusion and 8 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 14 Mar 2019. 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 Huiqiang Huang (13808885154, huanghq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of febrile neutropenia in cycles 1 to 6 (time frame: through 1-6 cycles of PEG-rhG-CSF,an average of 6 month). 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 14 Mar 2019.