LymphomaNCT04497701
Evaluate the Efficacy and Safety of the Prophylactic Use of PEG-rhG-CSF in Children With Hematological Malignancies
A study testing PEG-rhG-CSF group and rhG-CSF group in people with Lymphoma and Leukemia, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The incidence of infectious complications in hematological malignancies is higher than that in children with solid tumors, which may be related to the type and dose intensity of chemotherapy regimens used in hematological tumors. Read more about this study
- Who is it for?
- Ages Up to 18 years
- What is being tested?
- PEG-rhG-CSF group and rhG-CSF group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 1 Dec 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Under the age of 18, no gender limit;
- Children with hematological malignancies, leukemia or lymphoma, diagnosed by bone marrow pathology or cytology;
- The prophylactic use of PEG-rhG-CSF or rhG-CSF after chemotherapy is intended to prevent neutropenia, and the chemotherapy regimen must meet the interval between two chemotherapy sessions at least 12 days;
- The effect of chemotherapy in leukemia patients was complete remission, while that in lymphoma patients was complete remission or partial remission;
- The expected survival time is more than 8 months;
- Liver and kidney function: Liver function: total bilirubin (TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal value, or≤5 times the upper limit of normal value when there is liver metastasis; renal function test: serum creatinine (Cr) ≤ 1.5 times the upper limit of normal value;
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- Eastern Cooperative Oncology Group(ECOG) performance status(PS) <2;
- The subjects had good mental consciousness, and the subject's legal guardian must sign an informed consent form;
- Researchers believe that the subject can benefit;
Who cannot join
- Severe internal organ dysfunction;
- Those who used other test drugs of the same kind or accepted other clinical trials within 4 weeks before enrollment;
- Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
- Researchers determine unsuited to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai
Xiaowen Zhai, Doctor, 86-18017590808, zhaixiaowendy@163.com
About this study
Official title: A Multi-center, Open-label, Randomized Controlled Study to Evaluate the Efficacy and Safety of the Prophylactic Use of Pegylated Recombinant Human Granulocyte Colony Stimulating Factor After Chemotherapy in Children With Hematological Malignancies
The incidence of infectious complications in hematological malignancies is higher than that in children with solid tumors, which may be related to the type and dose intensity of chemotherapy regimens used in hematological tumors. The treatment of childhood cancer has changed in the past few decades: intensive treatment and good supportive treatment can improve the 5-year survival rate of children. The aim of this study was to evaluate the efficacy and safety of prophylactic use of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) after chemotherapy in children with hematological malignancies.
- Being tested
- PEG-rhG-CSF group, rhG-CSF group
- Medical subject headings
- Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhG-CSF groupDrug
Patients received a single dose of 100 ug/kg of PEG-rhG-CSF（Jinyouli®）, on the basis of actual body weight. Peg-rhG-CSF can be used prophylactically only when the interval between two chemotherapy regimens is no less than 12 days.
rhG-CSF groupDrug
Patients received 5μg/kg/d of rhG-CSF, on the basis of actual body weight.
| Study group | Role | What they receive |
|---|---|---|
| PEG-rhG-CSF group | Experimental | Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®)24~72 hours after the end of chemotherapy, 100µg/kg, once in each chemotherapy cycle. Receives: Drug: PEG-rhG-CSF group |
| rhG-CSF group | Active comparator | Patients received subcutaneous injection of rhG-CSF 24~72 hours after the end of chemotherapy, 100µg/kg/d, and stop using it until the ANC value exceeds the lowest value for 2 consecutive days> 0.5×10^9/L. Receives: Drug: rhG-CSF group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of febrile neutropenia (FN)
ANC<0.5×10^9/L or ANC (0.5-0.9)×10^9/L, and predicted to drop to ≤0.5×10^9/L in the next 48 hours, and the oral cavity temperature is ≥38.3℃ or ≥38.0℃ for more than 1 hour.
Measured: From date of randomization until the date of the study completion, up to 24 weeks.
Secondary outcomes (7)
Duration of febrile neutropenia
Defined as days when the FN occurs to the time when FN disappears.
Measured: From date of randomization until the date of the study completion, up to 24 weeks.
Incidence and duration of grade IV neutropenia (ANC<0.5×10^9/L)
Grade IV neutropenia is defined as the absolute neutrophil count(ANC)<0.5×10^9/L; Duration of grade IV neutropenia is 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 24 weeks.
Recovery time of grade IV neutropenia
Time from the first day of chemotherapy to ANC≥0.5×10^9/L
Measured: From date of randomization until the date of the study completion, up to 24 weeks.
Dynamic curve of absolute neutrophil count (ANC)
Dynamic changes of ANC after chemotherapy
Measured: From date of randomization until the date of the study completion, up to 24 weeks.
Hospital stay
Number of days the patient was hospitalized
Measured: From date of randomization until the date of the study completion, up to 24 weeks.
Incidence of infection
Incidence of various infections
Measured: From date of randomization until the date of the study completion, up to 24 weeks.
Dose adjustment of chemotherapy or delay of chemotherapy
Dose adjustment of chemotherapy is defined as incidence of 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 Aug 2020 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of Fudan University
- Responsible party
- Sponsor
- Investigators
- Xiaowen Zhai, Doctor, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497701
- Sponsor's protocol ID
- CSPC-JYL-CHIL-01
- 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, Randomized Controlled Study to Evaluate the Efficacy and Safety of the Prophylactic Use of Pegylated Recombinant Human Granulocyte Colony Stimulating Factor After Chemotherapy in Children With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT04497701
- Acronym / sponsor ID
- CSPC-JYL-CHIL-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of Fudan University
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Dec 2021 (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 incidence of infectious complications in hematological malignancies is higher than that in children with solid tumors, which may be related to the type and dose intensity of chemotherapy regimens used in hematological tumors. The treatment of childhood cancer has changed in the past few decades: intensive treatment and good supportive treatment can improve the 5-year survival rate of children. The aim of this study was to evaluate the efficacy and safety of prophylactic use of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) after chemotherapy in children with hematological malignancies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-rhG-CSF group | Experimental | Drug: PEG-rhG-CSF groupPatients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®)24~72 hours after the end of chemotherapy, 100µg/kg, once in each chemotherapy cycle. |
| rhG-CSF group | Active comparator | Drug: rhG-CSF groupPatients received subcutaneous injection of rhG-CSF 24~72 hours after the end of chemotherapy, 100µg/kg/d, and stop using it until the ANC value exceeds the lowest value for 2 consecutive days> 0.5×10^9/L. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Under the age of 18, no gender limit;
- Children with hematological malignancies, leukemia or lymphoma, diagnosed by bone marrow pathology or cytology;
- The prophylactic use of PEG-rhG-CSF or rhG-CSF after chemotherapy is intended to prevent neutropenia, and the chemotherapy regimen must meet the interval between two chemotherapy sessions at least 12 days;
- The effect of chemotherapy in leukemia patients was complete remission, while that in lymphoma patients was complete remission or partial remission;
- The expected survival time is more than 8 months;
Key exclusion criteria (4 listed)
- Severe internal organ dysfunction;
- Those who used other test drugs of the same kind or accepted other clinical trials within 4 weeks before enrollment;
- Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
- Researchers determine unsuited to participate in this trial.
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-CSF groupPatients received a single dose of 100 ug/kg of PEG-rhG-CSF（Jinyouli®）, on the basis of actual body weight. Peg-rhG-CSF can be used prophylactically only when the interval between two chemotherapy regimens is no less than 12 days. | Drug | PEG-rhG-CSF group |
| rhG-CSF groupPatients received 5μg/kg/d of rhG-CSF, on the basis of actual body weight. | Drug | rhG-CSF group |
Primary outcome
Incidence of febrile neutropenia (FN)
Time frame: From date of randomization until the date of the study completion, up to 24 weeks.
ANC<0.5×10^9/L or ANC (0.5-0.9)×10^9/L, and predicted to drop to ≤0.5×10^9/L in the next 48 hours, and the oral cavity temperature is ≥38.3℃ or ≥38.0℃ for more than 1 hour.
7 secondary outcomes
Duration of febrile neutropenia
Time frame: From date of randomization until the date of the study completion, up to 24 weeks.
Incidence and duration of grade IV neutropenia (ANC<0.5×10^9/L)
Time frame: From date of randomization until the date of the study completion, up to 24 weeks.
Recovery time of grade IV neutropenia
Time frame: From date of randomization until the date of the study completion, up to 24 weeks.
Dynamic curve of absolute neutrophil count (ANC)
Time frame: From date of randomization until the date of the study completion, up to 24 weeks.
Hospital stay
Time frame: From date of randomization until the date of the study completion, up to 24 weeks.
Incidence of infection
Time frame: From date of randomization until the date of the study completion, up to 24 weeks.
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.
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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.
Xiaowen Zhai, Doctor principal investigator
Children's Hospital of Fudan University
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 group and rhG-CSF group in people with Lymphoma and Leukemia, 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 9 inclusion and 4 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 Xiaowen Zhai, Doctor (86-18017590808, zhaixiaowendy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of febrile neutropenia (FN) (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.