Chemotherapy-Induced Febrile NeutropeniaPhase 4NCT06616571
Compare the Efficacy and Safety of QL0605 Injections at Different Timepoints
A Phase 4 study testing QL0605(PEG-rhG-CSF) in people with Chemotherapy-Induced Febrile Neutropenia, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The goal of this real-world study is to compare the efficacy and safety of QL0605 administered 24 hours and 48 hours after chemotherapy in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-Induced Febrile Neutropenia
- What is being tested?
- QL0605(PEG-rhG-CSF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteChina
- Study dates
- 19 Sep 2024to 30 Dec 2025
- Phase
- Phase 4
- 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
- Aged≥18 years；
- The expected survival period is more than 3 months;
- ECOG≤ 2;
- Invasive breast cancer diagnosed by histopathology;
- Plan to receive TAC, TC or TCbH chemotherapy;
- Subjects with good hematology, liver, lung and kidney function ;
- Signed informed consent.
Who cannot join
- Known hypersensitivity to rhG-CSF or PEG-rhG-CSF;
- Female patients during pregnancy or lactation;
- The previous malignant tumors were not cured;
- Received chemotherapy or radiotherapy within 4 weeks before screening;
- Received PEG-rhG-CSF within 6 weeks before screening;
- Suffering from uncontrollable infectious diseases within 2 weeks before screening.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Wangwang Zhi
About this study
Official title: A Randomized, Open-label, Interventional, Real-world Study to Compare the Efficacy and Safety of QL0605 Administered at Different Timepoints After Chemotherapy.
The goal of this real-world study is to compare the efficacy and safety of QL0605 administered 24 hours and 48 hours after chemotherapy in breast cancer patients.
Read the detailed description
Patients with stage invasive breast cancer who were scheduled to receive at least 2 cycles of adjuvant or neoadjuvant chemotherapy with TAC/TC/TCbH regimen were eligible for this multicenter, open-label, randomized trial. Patients were randomized (2:1) to receive QL0605 24 hours (24h group) or 48 hours (48h group) after the end of each cycle of chemotherapy. The primary endpoint was the incidence rate of FN for cycle 1. The secondary endpoints included the incidence rates of grade 3/4 neutropenia, chemotherapy dose reduction and chemotherapy delay due to neutropenia, antibiotic administration, the pain (bone, muscle, or joint), ect.
- Conditions
- Chemotherapy-Induced Febrile Neutropenia
- Being tested
- QL0605(PEG-rhG-CSF)
- Keywords
- Febrile Neutropenia, Breast Cancer, Chemotherapy
- Medical subject headings
- Chemotherapy-Induced Febrile Neutropenia, Febrile Neutropenia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL0605(PEG-rhG-CSF)Drug
Eligible patients are scheduled to receive 2 cycles of chemotherapy every three weeks. During each chemotherapy cycle QL0605 is injected 24 hours s.c. post chemotherapy application.
QL0605(PEG-rhG-CSF)Drug
Eligible patients are scheduled to receive 2 cycles of chemotherapy every three weeks. During each chemotherapy cycle QL0605 is injected 48 hours s.c. post chemotherapy application.
| Study group | Role | What they receive |
|---|---|---|
| 24h group | Experimental | Not described Receives: Drug: QL0605(PEG-rhG-CSF) |
| 48h group | Active comparator | Not described Receives: Drug: QL0605(PEG-rhG-CSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of febrile neutropenia for chemotherapy cycle 1.
Febrile neutropenia is defined as single temperature: ≥38.3 °C orally（axillary 38.1°C） or ≥38.0 °C（axillary 37.8°C） over 2h; and neutropenia: <500 neutrophils/mcL.
Measured: 21 days (Cycle 1 of chemotherapy treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start19 Sep 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced Febrile NeutropeniaStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616571
- Sponsor's protocol ID
- QL0605-401
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 27 Sep 2024
- 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 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Interventional, Real-world Study to Compare the Efficacy and Safety of QL0605 Administered at Different Timepoints After Chemotherapy.
- ClinicalTrials.gov ID
- NCT06616571
- Acronym / sponsor ID
- QL0605-401
- Conditions
- Chemotherapy-Induced Febrile Neutropenia
- Keywords
- Febrile Neutropenia, Breast Cancer, Chemotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 27 Sep 2024 (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 goal of this real-world study is to compare the efficacy and safety of QL0605 administered 24 hours and 48 hours after chemotherapy in breast cancer patients.
Detailed description
Patients with stage invasive breast cancer who were scheduled to receive at least 2 cycles of adjuvant or neoadjuvant chemotherapy with TAC/TC/TCbH regimen were eligible for this multicenter, open-label, randomized trial. Patients were randomized (2:1) to receive QL0605 24 hours (24h group) or 48 hours (48h group) after the end of each cycle of chemotherapy. The primary endpoint was the incidence rate of FN for cycle 1. The secondary endpoints included the incidence rates of grade 3/4 neutropenia, chemotherapy dose reduction and chemotherapy delay due to neutropenia, antibiotic administration, the pain (bone, muscle, or joint), ect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 24h group | Experimental | Drug: QL0605(PEG-rhG-CSF) |
| 48h group | Active comparator | Drug: QL0605(PEG-rhG-CSF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged≥18 years；
- The expected survival period is more than 3 months;
- ECOG≤ 2;
- Invasive breast cancer diagnosed by histopathology;
- Plan to receive TAC, TC or TCbH chemotherapy;
Key exclusion criteria (6 listed)
- Known hypersensitivity to rhG-CSF or PEG-rhG-CSF;
- Female patients during pregnancy or lactation;
- The previous malignant tumors were not cured;
- Received chemotherapy or radiotherapy within 4 weeks before screening;
- Received PEG-rhG-CSF within 6 weeks before screening;
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 |
|---|---|---|
| QL0605(PEG-rhG-CSF)Eligible patients are scheduled to receive 2 cycles of chemotherapy every three weeks. During each chemotherapy cycle QL0605 is injected 24 hours s.c. post chemotherapy application. | Drug | 24h group, 48h group |
| QL0605(PEG-rhG-CSF)Eligible patients are scheduled to receive 2 cycles of chemotherapy every three weeks. During each chemotherapy cycle QL0605 is injected 48 hours s.c. post chemotherapy application. | Drug | 24h group, 48h group |
Primary outcome
The incidence of febrile neutropenia for chemotherapy cycle 1.
Time frame: 21 days (Cycle 1 of chemotherapy treatment)
Febrile neutropenia is defined as single temperature: ≥38.3 °C orally（axillary 38.1°C） or ≥38.0 °C（axillary 37.8°C） over 2h; and neutropenia: <500 neutrophils/mcL.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
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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 4 study testing QL0605(PEG-rhG-CSF) in people with Chemotherapy-Induced Febrile Neutropenia, run by Qilu Pharmaceutical 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 7 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 27 Sep 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Mengli Zhu, Master (13256715221, mengli.zhu@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of febrile neutropenia for chemotherapy cycle 1. (time frame: 21 days (Cycle 1 of chemotherapy treatment)). 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 27 Sep 2024.