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

NCT04466137 | Completed Phase 3

• 1 other identifier: TB1801CSF
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Myeloid Malignancy

Keywords

G-CSF; Human Granulocyte Colony-Stimulating Factor; Febrile Neutropenia; Neutropenia; Myelosuppressive Chemotherapy; FN

Outcome Measures

Primary Outcomes (1)

• Mean Duration of Severe Neutropenia (DSN) During Cycle 1.

  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 Outcomes (9)

• Incidence of Febrile neutropenia(FN).

  Cycle1 to Cycle 4(21 days one cycle)

• Mean duration of DSN.

  Cycle2 to Cycle 4 (21 days one cycle)

• Incidence of Grade 3 neutropenia.

  Cycle1 to Cycle 4 ( 21 days one cycle)

• Mean duration of grade 3 neutropenia.

  Cycle1 to Cycle 4(21 days one cycle)

• Neutrophils dynamic changes from baseline.

  Cycle1 to Cycle 4 ( 21 days one cycle)

Study Arms (3)

YPEG-rhG-CSF 2mg

EXPERIMENTAL

YPEG-rhG-CSF 2mg

Drug: YPEG-rhG-CSF

YPEG-rhG-CSF 33μg/kg

EXPERIMENTAL

YPEG-rhG-CSF 33μg/kg

Drug: YPEG-rhG-CSF

Positive Control Group

ACTIVE COMPARATOR

rhG-CSF/PEG-rhG-CSF

Drug: rhG-CSF/PEG-rhG-CSF

Interventions

YPEG-rhG-CSF DRUG

YPEG-rhG-CSF 2mg, single s.c. at day 3 of each cycles, up to 4 cycles. 21 day one cycles.

YPEG-rhG-CSF 2mg

rhG-CSF/PEG-rhG-CSF DRUG

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.

Positive Control Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiamen Amoytop Biotech Co., Ltd.: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• Shi Y, Wang X, Pei Z, Shi H, Zhang Y, Yi T, Mei J, Guo Y, Dong Y, Ma T, Zhang Q, Jia X, Zhu Z, Xu S, Liu Y, Niu H, Jiang W, Jiang X, Zhou S, Sun L. Telpegfilgrastim for chemotherapy-induced neutropenia in patients with non-small cell lung cancer: a multicentre, randomized, phase 3 study. BMC Cancer. 2025 Mar 17;25(1):490. doi: 10.1186/s12885-025-13736-6.

  PMID: 40098083 DERIVED

MeSH Terms

Conditions

Febrile Neutropenia; Neutropenia

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 10, 2020
• Study Start: October 16, 2020
• Primary Completion: June 24, 2021
• Study Completion: September 1, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-01

Locations

CN (1)