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

NCT04773327 | Unknown

• 1 other identifier: MA-GynC-II-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gynecologic Malignant Tumor

Keywords

neutropenia

Outcome Measures

Primary Outcomes (1)

• Incidence of third/fourth level neutropenia

  Incidence of third/fourth level neutropenia during three cycles chemotherapy

  three months

Secondary Outcomes (6)

• Incidence of febrile neutropenia

  three months

• The duration time of third/fourth level neutropenia

  three months

• Incidence of infection

  three months

• delay time of chemotherapy

  three months

• RDI of chemotherapy

  three months

Study Arms (2)

PEG-rhG-CSF prevention

EXPERIMENTAL

Mecapegfilgrastim subcutaneous injection, 6mg, 24-48h after the end of antitumor drug administration in each chemotherapy cycle,

Other: Mecapegfilgrastim Injection

non-prevention

NO INTERVENTION

Only close monitoring after chemotherapy

Interventions

Mecapegfilgrastim Injection OTHER

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

Also known as: PEG- rhg - csf

PEG-rhG-CSF prevention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiaohua Wu MD: lead

Study Sites (1)

No. 270, Dongan Road, Xuhui District, Shanghai, China

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Neutropenia

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Xiaohua Wu, MD&PHD

  director of gynecologic oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingfang Xia, M.D.

CONTACT

13774211977; nightxlf@163.com

Xiaohua Wu, MD&PHD

CONTACT

+862164175590; alizheng@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director of gynecologic oncology

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 26, 2021
• Study Start: May 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: August 1, 2022
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)