- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04466137
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
398
Phase
- 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
-
-
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
Ages Eligible for Study
16 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 |
Intervention / Treatment |
---|---|
Experimental: YPEG-rhG-CSF 2mg
|
YPEG-rhG-CSF 2mg, single s.c. at day 3 of each cycles, up to 4 cycles.
21 day one cycles.
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
|
YPEG-rhG-CSF 2mg, single s.c. at day 3 of each cycles, up to 4 cycles.
21 day one cycles.
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
|
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
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
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.
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)
October 16, 2020
Primary Completion (Actual)
June 24, 2021
Study Completion (Actual)
September 1, 2021
Study Registration Dates
First Submitted
June 29, 2020
First Submitted That Met QC Criteria
July 6, 2020
First Posted (Actual)
July 10, 2020
Study Record Updates
Last Update Posted (Actual)
February 9, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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