Gynecologic Malignant TumorNCT04773327
Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemo in Pts With Gynecological Malignancies
A study testing Mecapegfilgrastim Injection in people with Gynecologic Malignant Tumor, run by Xiaohua Wu MD at 1 site in China.
Trial summary
This study is a multi-center, forward-looking, open, randomized, controlled clinical trial. This study aims to analyze the effects of Mecapegfilgrastim Injection prevention versus non-prevention for neutropenia in ovarian cancer, cervical cancer, endometrial cancer patients after chemical therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gynecologic Malignant Tumor
- What is being tested?
- Mecapegfilgrastim Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- May 2021to Aug 2022
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-70
- Weight ≥45 kg
- ≤2 lines chemotherapy or postoperative adjuvant chemotherapy patients with cervical cancer, ovarian cancer and endometrial cancer
- Receive paclitaxel combined with platinum three weeks per cycle of chemotherapy
- With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
- Expected survival time of > 3 months
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- Main organ functions meet the following criteria:
- Hb≥75g/L; WBC≥3.0×109/L; ANC≥1.5×109/L; PLT≥80×109/L;
- APTT-ULN≤10s; PT-ULN≤3s; TT-ULN≤3s;
- ALT≤2.5×ULN; AST≤2.5×ULN; TBIL≤2.5×ULN;
- BUN≤1.5×ULN; Cr≤1.5×ULN; UA≤1.5×ULN；Creatinine clearance≥40mL/min;
- without obvious cardiac dysfunction
- Provided consent for participation
Who cannot join
- With uncontrollable infections or receive systemic antibiotics within 72 hours prior to chemotherapy
- Pregnant or lactating women
- Received bone marrow or hematopoietic stem cell transplantation within the past 3 months
- Concurrent chemoradiotherapy
- Presence of hematological disorders: systemic lupus erythematosus, sjogren's syndrome, rheumatic autoimmune disease, mixed and hoof tissue disease, autoimmune hemolytic anemia, leukopenia , chronic granulocyte leukemia, bone marrow dysplasia syndrome, aplastic anemia, congenital and idiopathic neutropenia, myelodysplastic syndrome, cyclic neutropenia, primary and secondary thrombocytopenic purpura, etc
- Presence of risk of thrombus or high risk of clotting
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- Presence of psychosis, neurological disease or brain metastases from tumors
- Presence of uncontrollable complicated disease including symptomatic congestive heart failure, uncontrollable hypertension, unstable angina pectoris, active peptic ulcer, or hemorrhagic disease
- Presence of uncontrollable infectious diseases, active viral hepatitis, tuberculosis, HIV
- Allergic to recombinant human granulocyte stimulating factor or other biological products of E. coli origin
- Received clinical trials within 1 month prior to enrollment
Trial locations and contacts
1 site in 1 country.
China1 site
No. 270, Dongan Road, Xuhui District, Shanghai, China
Shanghai, Shanghai Municipality
Xiaohua Wu, +862164175590, alizheng@126.com
About this study
Official title: A Multicenter, Randomized Controlled, Open Clinical Study of the Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemotherapy in Patients With Gynecological Malignancies
This study is a multi-center, forward-looking, open, randomized, controlled clinical trial. This study aims to analyze the effects of Mecapegfilgrastim Injection prevention versus non-prevention for neutropenia in ovarian cancer, cervical cancer, endometrial cancer patients after chemical therapy.
Patients are randomized into study group and control group. All patients receive PTX+platinum chemotherapy of 3 weeks. In study group, patients accept PEG-rhG-CSF 24-48 hours from the chemotherapy. While the control group patients are only observed closely. Patient receive three courses of treatment.
Read more
The primary end is the incidence of 3/4 level neutropenia in three courses of chemotherapy.
The secondary ends include: the incidences and duration of neutropenia in every course of chemotherapy, the incidences of FN in three courses and every course of chemotherapy, the incidences of infection in three courses and every course of chemotherapy, the delay time of the next cycle of chemotherapy due to FN or infection, the RDI of the second and third cycles of chemotherapy, adverse events related to G-CSF, quality of life, cost of medicine and admitting.
- Conditions
- Gynecologic Malignant Tumor
- Being tested
- Mecapegfilgrastim Injection
- Keywords
- neutropenia
- Medical subject headings
- Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mecapegfilgrastim InjectionOther
Also called PEG- rhg - csf
24-48h after the end of antitumor drug administration in each chemotherapy cycle, Mecapegfilgrastim was injected subcutaneously, 6mg/ time, once/cycle
| Study group | Role | What they receive |
|---|---|---|
| PEG-rhG-CSF prevention | Experimental | Mecapegfilgrastim subcutaneous injection, 6mg, 24-48h after the end of antitumor drug administration in each chemotherapy cycle, Receives: Other: Mecapegfilgrastim Injection |
| non-prevention | No intervention | Only close monitoring after chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of third/fourth level neutropenia
Incidence of third/fourth level neutropenia during three cycles chemotherapy
Measured: three months
Secondary outcomes (6)
Incidence of febrile neutropenia
Incidence of febrile neutropenia during every cycle chemotherapy
Measured: three months
The duration time of third/fourth level neutropenia
The duration time of third/fourth level neutropenia during three cycles chemotherapy
Measured: three months
Incidence of infection
Incidence of third/fourth level neutropenia during three cycles chemotherapy
Measured: three months
delay time of chemotherapy
The delay time of the next cycle of chemotherapy due to FN or infection
Measured: three months
RDI of chemotherapy
Relative dose intensity of the second and third chemotherapy
Measured: three months
Adverse events
Incidence of adverse events related to granulocyte colony stimulating factor according to common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study startMay 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic Malignant TumorStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaohua Wu MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaohua Wu MD, Fudan University
- Investigators
- Xiaohua Wu, MD&PHD, Principal investigator, director of gynecologic oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773327
- Sponsor's protocol ID
- MA-GynC-II-001
- Status last verified
- Feb 2021
- First submitted
- 2 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data is available per require after approved by ethics broad
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled, Open Clinical Study of the Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemotherapy in Patients With Gynecological Malignancies
- ClinicalTrials.gov ID
- NCT04773327
- Acronym / sponsor ID
- MA-GynC-II-001
- Conditions
- Gynecologic Malignant Tumor
- Keywords
- neutropenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xiaohua Wu MDUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 26 Feb 2021 (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.
This study is a multi-center, forward-looking, open, randomized, controlled clinical trial. This study aims to analyze the effects of Mecapegfilgrastim Injection prevention versus non-prevention for neutropenia in ovarian cancer, cervical cancer, endometrial cancer patients after chemical therapy.
Patients are randomized into study group and control group. All patients receive PTX+platinum chemotherapy of 3 weeks. In study group, patients accept PEG-rhG-CSF 24-48 hours from the chemotherapy. While the control group patients are only observed closely. Patient receive three courses of treatment.
The primary end is the incidence of 3/4 level neutropenia in three courses of chemotherapy.
The secondary ends include: the incidences and duration of neutropenia in every course of chemotherapy, the incidences of FN in three courses and every course of chemotherapy, the incidences of infection in three courses and every course of chemotherapy, the delay time of the next cycle of chemotherapy due to FN or infection, the RDI of the second and third cycles of chemotherapy, adverse events related to G-CSF, quality of life, cost of medicine and admitting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-rhG-CSF prevention | Experimental | Other: Mecapegfilgrastim InjectionMecapegfilgrastim subcutaneous injection, 6mg, 24-48h after the end of antitumor drug administration in each chemotherapy cycle, |
| non-prevention | No intervention | –Only close monitoring after chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Ages 18-70
- Weight ≥45 kg
- ≤2 lines chemotherapy or postoperative adjuvant chemotherapy patients with cervical cancer, ovarian cancer and endometrial cancer
- Receive paclitaxel combined with platinum three weeks per cycle of chemotherapy
- With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
Key exclusion criteria (11 listed)
- With uncontrollable infections or receive systemic antibiotics within 72 hours prior to chemotherapy
- Pregnant or lactating women
- Received bone marrow or hematopoietic stem cell transplantation within the past 3 months
- Concurrent chemoradiotherapy
- Presence of hematological disorders: systemic lupus erythematosus, sjogren's syndrome, rheumatic autoimmune disease, mixed and hoof tissue disease, autoimmune hemolytic anemia, leukopenia , chronic granulocyte leukemia, bone marrow dysplasia syndrome, aplastic anemia, congenital and idiopathic neutropenia, myelodysplastic syndrome, cyclic neutropenia, primary and secondary thrombocytopenic purpura, etc
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 |
|---|---|---|
| Mecapegfilgrastim InjectionAlso: PEG- rhg - csf24-48h after the end of antitumor drug administration in each chemotherapy cycle, Mecapegfilgrastim was injected subcutaneously, 6mg/ time, once/cycle | Other | PEG-rhG-CSF prevention |
Primary outcome
Incidence of third/fourth level neutropenia
Time frame: three months
Incidence of third/fourth level neutropenia during three cycles chemotherapy
6 secondary outcomes
Incidence of febrile neutropenia
Time frame: three months
The duration time of third/fourth level neutropenia
Time frame: three months
Incidence of infection
Time frame: three months
delay time of chemotherapy
Time frame: three months
RDI of chemotherapy
Time frame: three months
Adverse events
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: No. data is available per require after approved by ethics broad
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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.
Xiaohua Wu, MD&PHD principal investigator
director of gynecologic oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mecapegfilgrastim Injection in people with Gynecologic Malignant Tumor, run by Xiaohua Wu MD 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 13 inclusion and 11 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 26 Feb 2021. 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 Lingfang Xia, M.D. (13774211977, nightxlf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of third/fourth level neutropenia (time frame: three months). 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 26 Feb 2021.