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Completed

NCT Number: NCT04466137

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

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Key information

Conditions

Non-Myeloid Malignancy Agranulocytosis Cytopenia Febrile Neutropenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neutropenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. Mean duration of DSN.

    Time frame: Cycle2 to Cycle 4 (21 days one cycle)

  3. 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.

  4. Mean duration of grade 3 neutropenia.

    Time frame: Cycle1 to Cycle 4(21 days one cycle)

  5. Neutrophils dynamic changes from baseline.

    Time frame: Cycle1 to Cycle 4 ( 21 days one cycle)

  6. Time of neutrophils recovering to over 2.0×10^9 cells/L after nadir.

    Time frame: Cycle1 to Cycle 4 (21 days one cycle)

  7. Proportion of patients with antibiotic usage.

    Time frame: Cycle1 to Cycle 4 ( 21 days one cycle)

  8. Proportion of patients experienced infection.

    Time frame: Cycle1 to Cycle 4 ( 21 days one cycle)

  9. Proportion of patients fulfilling expected chemotherapy.

    Time frame: Cycle1 to Cycle 4 (21 days one cycle)

Sponsors and collaborators

Lead sponsor

Xiamen Amoytop Biotech Co., Ltd.

Industry

Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Registry information

Official study title

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.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 10, 2020
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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