Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemo in Pts With Gynecological Malignancies

Gynecologic Malignant Tumor Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04773327
• Other study ID #: MA-GynC-II-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2021
• Est. completion date: August 2022

Study information

• Verified date: February 2021
• Source: Fudan University
• Contact: Lingfang Xia, M.D.
• Phone: 13774211977
• Email: nightxlf[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

• Main organ functions meet the following criteria:

1. Hb=75g/L; WBC=3.0×109/L; ANC=1.5×109/L; PLT=80×109/L;

2. APTT-ULN=10s; PT-ULN=3s; TT-ULN=3s;

3. ALT=2.5×ULN; AST=2.5×ULN; TBIL=2.5×ULN;

4. BUN=1.5×ULN; Cr=1.5×ULN; UA=1.5×ULN;Creatinine clearance=40mL/min;

5. without obvious cardiac dysfunction

• Provided consent for participation

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Gynecologic Malignant Tumor
• Neoplasms
• Neutropenia

Intervention

Other:
• Mecapegfilgrastim Injection
24-48h after the end of antitumor drug administration in each chemotherapy cycle, Mecapegfilgrastim was injected subcutaneously, 6mg/ time, once/cycle

Locations

Country	Name	City	State
China	No. 270, Dongan Road, Xuhui District, Shanghai, China	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xiaohua Wu MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of third/fourth level neutropenia	Incidence of third/fourth level neutropenia during three cycles chemotherapy	three months
Secondary	Incidence of febrile neutropenia	Incidence of febrile neutropenia during every cycle chemotherapy	three months
Secondary	The duration time of third/fourth level neutropenia	The duration time of third/fourth level neutropenia during three cycles chemotherapy	three months
Secondary	Incidence of infection	Incidence of third/fourth level neutropenia during three cycles chemotherapy	three months
Secondary	delay time of chemotherapy	The delay time of the next cycle of chemotherapy due to FN or infection	three months
Secondary	RDI of chemotherapy	Relative dose intensity of the second and third chemotherapy	three months
Secondary	Adverse events	Incidence of adverse events related to granulocyte colony stimulating factor according to common Terminology Criteria for Adverse Events (CTCAE) v5.0	three months