Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF in Malignancies Receiving Chemotherapy

February 7, 2022 updated by: Xiamen Amoytop Biotech Co., Ltd.

A Multi-centers, Randomized, Open-labeled, Positive-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF, Once-per-cycle, in Patients With Malignancies Receiving Myelosuppressive Chemotherapy.

This phase 3 study is aimed to evaluate the safety and efficacy of YPEG-rhG-CSF in reducing the infection manifested by febrile neutropenia in patients with non-myeloid malignancy who receiving Myelosuppressive Chemotherapy which is likely to cause clinically significant febrile neutropenia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
398

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Cancer Hospital Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histopathology and/or cytology diagnosed as breast cancer (BC) or non-small cell lung cancer (NSCLC), and patients with breast cancer is suitable to receive TAC(Docetaxel,Doxorubicin combined with Cyclophosphamide) chemotherapy, while patients with NSCLC is suitable to receive DC(Docetaxel combined with Carboplatin) chemotherapy.
  • Age ≥18 yrs.
  • Weight ≥45 kg.
  • Karnofsky Score ≥ 70.
  • Life Expectancy ≥ 3 months.
  • Peripheral blood test: WBC≥3.5×10^9 cells/L, PLT≥100×10^9 cells/L. ANC≥1.5×10^9 cells/L.
  • Understand and voluntarily sign the informed consent form.

Exclusion Criteria:

  • Receiving chemotherapy within two months prior to screening.
  • Previously or plan to receive radiotherapy (>25% total bone marrow volume).
  • Evidence of tumor metastasis in bone marrow.
  • Lack of awareness.
  • Uncontrolled infection or using of antibiotics within 72hrs prior to screening.
  • Previously received or plan to undergoing bone marrow or organ transplants.
  • Patients with bleeding tendency, e.g. prolonged prothrombin time of more than 3 seconds.
  • Dysfunction in heart,lung, liver, kidney, or other major organs or systems; ALT>2.5 ULN (upper limit of normal), TBil >2.5 ULN (ALT>2.5 ULN, total bilirubin >2.5 ULN for patients with liver metastasis), HBsAg positive, anti-HCV positive, evidence of liver decompensation, or Cr >1.5 ULN.
  • Pregnant or lactating females.
  • Malignancy other than BC or NSCLC.
  • Hypersensitivity to rhG-CSF or any component of the investigational Products.
  • Subject enrolled in any other studies within 3 months prior to screening.
  • Drug abuser or alcoholics.
  • Any other conditions which in the opinion of the investigator precluded enrollment into the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: YPEG-rhG-CSF 2mg
Drug: YPEG-rhG-CSF
YPEG-rhG-CSF 2mg, single s.c. at day 3 of each cycles, up to 4 cycles. 21 day one cycles.
Drug: YPEG-rhG-CSF
YPEG-rhG-CSF 33μg/kg, single s.c. at day 3 of each cycles, up to 4 cycles. 21 day one cycles.
Experimental: YPEG-rhG-CSF 33μg/kg
Drug: YPEG-rhG-CSF
YPEG-rhG-CSF 2mg, single s.c. at day 3 of each cycles, up to 4 cycles. 21 day one cycles.
Drug: YPEG-rhG-CSF
YPEG-rhG-CSF 33μg/kg, single s.c. at day 3 of each cycles, up to 4 cycles. 21 day one cycles.
Active Comparator: Positive Control Group
rhG-CSF/PEG-rhG-CSF
Drug: rhG-CSF/PEG-rhG-CSF
rhG-CSF 5μg/kg/day, s.c. from day 3 to day 14 or until neutrophils recover to exceed 5.0×10^9 cells/L, whichever comes first, in the first cycle. Patient can still continue rhG-CSF 5μg/kg/day, or covert to PEG-rhG-CSF 6mg/Cycle in the following 2-4 cycle. 21 day one cycles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Duration of Severe Neutropenia (DSN) During Cycle 1.
Time Frame: At the end of Cycle 1 (21 days one cycle)
Mean duration of severe neutropenia, defined as number of consecutive days with absolute neutrophil count (ANC) <0.5 × 10^9 cells/l (grade 4 neutropenia)
At the end of Cycle 1 (21 days one cycle)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Febrile neutropenia(FN).
Time Frame: Cycle1 to Cycle 4(21 days one cycle)
FN defines as the ANC counts is less than < 0.5 × 10^9 cells/L or ANC counts between 0.5 × 10^9 cells/L and 1.0 × 10^9 cells/L but probably to decline to less than 0.5×10^9 cells/L within 48hrs, and body temperature is higher than 38.3 degrees Celsius or higher than 38.0 degrees Celsius and lasting for more than 1hr.
Cycle1 to Cycle 4(21 days one cycle)
Mean duration of DSN.
Time Frame: Cycle2 to Cycle 4 (21 days one cycle)
Cycle2 to Cycle 4 (21 days one cycle)
Incidence of Grade 3 neutropenia.
Time Frame: Cycle1 to Cycle 4 ( 21 days one cycle)
Grade 3 neutropenia defines as the ANC count is less than 1.0×10^9 cells/L.
Cycle1 to Cycle 4 ( 21 days one cycle)
Mean duration of grade 3 neutropenia.
Time Frame: Cycle1 to Cycle 4(21 days one cycle)
Cycle1 to Cycle 4(21 days one cycle)
Neutrophils dynamic changes from baseline.
Time Frame: Cycle1 to Cycle 4 ( 21 days one cycle)
Cycle1 to Cycle 4 ( 21 days one cycle)
Time of neutrophils recovering to over 2.0×10^9 cells/L after nadir.
Time Frame: Cycle1 to Cycle 4 (21 days one cycle)
Cycle1 to Cycle 4 (21 days one cycle)
Proportion of patients with antibiotic usage.
Time Frame: Cycle1 to Cycle 4 ( 21 days one cycle)
Cycle1 to Cycle 4 ( 21 days one cycle)
Proportion of patients experienced infection.
Time Frame: Cycle1 to Cycle 4 ( 21 days one cycle)
Cycle1 to Cycle 4 ( 21 days one cycle)
Proportion of patients fulfilling expected chemotherapy.
Time Frame: Cycle1 to Cycle 4 (21 days one cycle)
Cycle1 to Cycle 4 (21 days one cycle)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiamen Amoytop Biotech Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 24, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TB1801CSF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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