RecruitingPhase 2NCT06251947

Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen

A Study of Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen With Risk Factors:A Single-Arm, Multicenter Clinical Trial


Sponsor

Shandong University

Enrollment

83 participants

Start Date

Apr 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study was to observe the efficacy and safety of Efbemalenograstim Alfa in the prevention of absolute neutrophil count (ANC) reduction after chemotherapy in Ovarian and Cervical cancer patients at risk of platinum-containing chemotherapy with risk factors in febrile neutropenia (FN).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a white blood cell booster injection called efbemalenograstim alfa in women receiving chemotherapy for ovarian or cervical cancer. The goal is to see if this drug can help prevent a dangerous drop in infection-fighting white blood cells (a condition called febrile neutropenia). **You may be eligible if...** - You are a woman aged 18–70 with ovarian, fallopian tube, peritoneal, or cervical cancer - You are planned to receive paclitaxel + carboplatin or cisplatin (with or without bevacizumab) chemotherapy - You have at least one risk factor for low white blood cell counts (e.g., age over 65, prior chemo or radiation, or poor nutrition) - Your heart, blood counts, and organ function meet the study's minimum requirements **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have an active, uncontrolled infection - You have had a bone marrow or stem cell transplant - You have been treated with a similar white blood cell stimulating drug in the past 6 weeks - You have HIV, active tuberculosis, hepatitis B or C, or sickle cell anemia - You have had a recent heart attack or severe heart failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEfbemalenograstim Alfa

Efbemalenograstim Alfa is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.


Locations(6)

Xiangya Hospital, Central South University,

Changsha, Hunan, China

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Qingdao Central Hospital, The Second Affiliated Hospital of Medical College of Qingdao University,

Qingdao, Shandong, China

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06251947


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