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

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Gynecologic Malignant Tumor
• Intervention / Treatment: Other: Mecapegfilgrastim Injection

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lingfang Xia, M.D.; Phone Number: 13774211977; Email: nightxlf@163.com
• Study Contact Backup: Name: Xiaohua Wu, MD&PHD; Phone Number: +862164175590; Email: alizheng@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • No. 270, Dongan Road, Xuhui District, Shanghai, China
      • Contact: Xiaohua Wu; Phone Number: +862164175590; Email: alizheng@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEG-rhG-CSF prevention; Mecapegfilgrastim subcutaneous injection, 6mg, 24-48h after the end of antitumor drug administration in each chemotherapy cycle,	Other: Mecapegfilgrastim Injection; 24-48h after the end of antitumor drug administration in each chemotherapy cycle, Mecapegfilgrastim was injected subcutaneously, 6mg/ time, once/cycle; Other Names: PEG- rhg - csf
No Intervention: non-prevention; Only close monitoring after chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of third/fourth level neutropenia	Incidence of third/fourth level neutropenia during three cycles chemotherapy	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of febrile neutropenia	Incidence of febrile neutropenia during every cycle chemotherapy	three months
The duration time of third/fourth level neutropenia	The duration time of third/fourth level neutropenia during three cycles chemotherapy	three months
Incidence of infection	Incidence of third/fourth level neutropenia during three cycles chemotherapy	three months
delay time of chemotherapy	The delay time of the next cycle of chemotherapy due to FN or infection	three months
RDI of chemotherapy	Relative dose intensity of the second and third chemotherapy	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	three months

Collaborators and Investigators

• Sponsor: Xiaohua Wu MD
• Investigators: Principal Investigator: Xiaohua Wu, MD&PHD, director of gynecologic oncology

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: neutropenia
• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neoplasms; Neutropenia
• Other Study ID Numbers: MA-GynC-II-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: data is available per require after approved by ethics broad

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No