Chemotherapy-induced NeutropeniaPhase 2NCT04460508
Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma
A Phase 2 study testing Pegylated rhG-CSF and rhG-CSF in people with Chemotherapy-induced Neutropenia and Lymphoma, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy.A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chemotherapy-induced Neutropenia, Lymphoma
- What is being tested?
- Pegylated rhG-CSF and rhG-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2020to 20 Mar 2023
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years;
- Patients with primary malignant lymphoma confirmed by histopathology or immunomolecular biology and requiring treatment with multi-cycle high-intensity chemotherapy regimen;
- ECOG performance status ≤ 1;
- ANC ≥1.5×109/L, PLT≥80×109 /L, Hb≥ 75g/L, WBC ≥3.0×109/L;
- Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment;
- Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedul.
Who cannot join
- Lymphoma central involvement;
- Recipients of hematopoietic stem cell transplantation or organ transplantation;
- Currently conducting clinical trials of other drugs;
- There is an uncontrollable infection with body temperature ≥38℃;
- liver function examination: total bilirubin (TBIL., alanine aminotransferase (ALT. and ascetic aminotransferase (AST. were all 2.5 times the upper limit of the normal value of >; if they were caused by liver metastasis, the upper limit of the normal value of > was 5 times;Renal function test: serum creatinine (Cr. >2 times the upper limit of normal value
- Patients with serious chronic diseases of heart, kidney, liver and other important organs;
- Patients with severe uncontrolled diabetes;
- Pregnant or lactating female patients.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021
Ou BAI, doctor, 13039046656, oubai16@163.com
About this study
Official title: Efficacy and Safety of Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma: a Randomized, Open-label, Active-controlled Trial
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy.A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with filgrastim.
This study is to evaluate efficacy and safety in chemotherapy-induced neutropenia of once-per-cycle Mecapegfilgrastim Injection(PEG-G-CSF) and daily G-CSF in Patients with lymphoma patients.
Read the detailed description
This is a randomized, controlled study. A total of 170 lymphoma patients who are eligible are planned to randomized assigned into two groups to receive mecapegfilgrastim fixed dose of 6 mg or filgrastim 5 µg/kg/day during chemotherapy.
The primary endpoint is the duration of grade ≥3 neutropenia in cycle 1. The secondary endpoints include incidence of grade ≥3 neutropenia and febrile neutropenia (FN) in cycle 1-4, The pharmacoeconomics and safety profile are also evaluated.
- Conditions
- Chemotherapy-induced Neutropenia, Lymphoma
- Being tested
- Pegylated rhG-CSF, rhG-CSF
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated rhG-CSFDrug
Pegylated rhG-CSF:6mg
rhG-CSFDrug
rhG-CSF:5ug/kg/d
| Study group | Role | What they receive |
|---|---|---|
| Mecapegfilgrastim | Experimental | Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. Receives: Drug: Pegylated rhG-CSF |
| rhG-CSF | Active comparator | Patients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle. Receives: Drug: rhG-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of grade ≥3 neutropenia in cycle 1
Duration of subjects developing ANC lower than 1.0 × 109/L
Measured: 21 days
Secondary outcomes (3)
Incidence of grade ≥3 neutropenia in cycle 1-4
Proportion of subjects developing ANC lower than 1.0 × 109/L from cycle 1 to cycle 4
Measured: 84 days
Incidenc of febrile neutropenia (FN) in cycle 1-4
Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.5 degrees celsius from cycle 1 to cycle 4
Measured: 84 days
Incidence of adverse events (AEs)
Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) according to the Common Terminology Criteria for Adverse Events, version 5.0
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start20 Dec 2020
- Primary completion20 Dec 2022 (estimated)
- Study completion20 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced NeutropeniaStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ou Bai, MD/PHD, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460508
- Sponsor's protocol ID
- mecapegfilgrastim-lym-2020-1
- Status last verified
- Jul 2022
- First submitted
- 28 Jun 2020
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma: a Randomized, Open-label, Active-controlled Trial
- ClinicalTrials.gov ID
- NCT04460508
- Acronym / sponsor ID
- mecapegfilgrastim-lym-2020-1
- Conditions
- Chemotherapy-induced Neutropenia, Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 20 Mar 2023 (estimated)
- First posted
- 7 Jul 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.
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy.A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with filgrastim.
This study is to evaluate efficacy and safety in chemotherapy-induced neutropenia of once-per-cycle Mecapegfilgrastim Injection(PEG-G-CSF) and daily G-CSF in Patients with lymphoma patients.
Detailed description
This is a randomized, controlled study. A total of 170 lymphoma patients who are eligible are planned to randomized assigned into two groups to receive mecapegfilgrastim fixed dose of 6 mg or filgrastim 5 µg/kg/day during chemotherapy.
The primary endpoint is the duration of grade ≥3 neutropenia in cycle 1. The secondary endpoints include incidence of grade ≥3 neutropenia and febrile neutropenia (FN) in cycle 1-4, The pharmacoeconomics and safety profile are also evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mecapegfilgrastim | Experimental | Drug: Pegylated rhG-CSFPatients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. |
| rhG-CSF | Active comparator | Drug: rhG-CSFPatients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 75 years;
- Patients with primary malignant lymphoma confirmed by histopathology or immunomolecular biology and requiring treatment with multi-cycle high-intensity chemotherapy regimen;
- ECOG performance status ≤ 1;
- ANC ≥1.5×109/L, PLT≥80×109 /L, Hb≥ 75g/L, WBC ≥3.0×109/L;
- Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment;
Key exclusion criteria (8 listed)
- Lymphoma central involvement;
- Recipients of hematopoietic stem cell transplantation or organ transplantation;
- Currently conducting clinical trials of other drugs;
- There is an uncontrollable infection with body temperature ≥38℃;
- liver function examination: total bilirubin (TBIL., alanine aminotransferase (ALT. and ascetic aminotransferase (AST. were all 2.5 times the upper limit of the normal value of >; if they were caused by liver metastasis, the upper limit of the normal value of > was 5 times;Renal function test: serum creatinine (Cr. >2 times the upper limit of normal value
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 |
|---|---|---|
| Pegylated rhG-CSFPegylated rhG-CSF:6mg | Drug | Mecapegfilgrastim |
| rhG-CSFrhG-CSF:5ug/kg/d | Drug | rhG-CSF |
Primary outcome
Duration of grade ≥3 neutropenia in cycle 1
Time frame: 21 days
Duration of subjects developing ANC lower than 1.0 × 109/L
3 secondary outcomes
Incidence of grade ≥3 neutropenia in cycle 1-4
Time frame: 84 days
Incidenc of febrile neutropenia (FN) in cycle 1-4
Time frame: 84 days
Incidence of adverse events (AEs)
Time frame: 84 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegylated rhG-CSF and rhG-CSF in people with Chemotherapy-induced Neutropenia and Lymphoma, run by The First Hospital of Jilin University 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 6 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 7 Jul 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of grade ≥3 neutropenia in cycle 1 (time frame: 21 days). 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 7 Jul 2022.