AzTrials
AzTrials

Non-Myeloid MalignancyPhase 3NCT04466137

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

A Phase 3 study testing YPEG-rhG-CSF and rhG-CSF/PEG-rhG-CSF in people with Non-Myeloid Malignancy, run by Xiamen Amoytop Biotech Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Myeloid Malignancy
What is being tested?
YPEG-rhG-CSF and rhG-CSF/PEG-rhG-CSF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
398 participants
Where
1 siteChina
Study dates
16 Oct 2020to 1 Sep 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

Other trials in China

About this study

Official 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.

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.

Being tested
YPEG-rhG-CSF, rhG-CSF/PEG-rhG-CSF
Keywords
G-CSF, Human Granulocyte Colony-Stimulating Factor, Febrile Neutropenia, Neutropenia, Myelosuppressive Chemotherapy, FN
Medical subject headings
Febrile Neutropenia, Neutropenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YPEG-rhG-CSFDrug

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

  • YPEG-rhG-CSFDrug

    YPEG-rhG-CSF 33μg/kg, single s.c. at day 3 of each cycles, up to 4 cycles. 21 day one cycles.

  • rhG-CSF/PEG-rhG-CSFDrug

    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.

Study groups in NCT04466137
Study groupRoleWhat they receive
YPEG-rhG-CSF 2mgExperimentalYPEG-rhG-CSF 2mg
Receives: Drug: YPEG-rhG-CSF
YPEG-rhG-CSF 33μg/kgExperimentalYPEG-rhG-CSF 33μg/kg
Receives: Drug: YPEG-rhG-CSF
Positive Control GroupActive comparatorrhG-CSF/PEG-rhG-CSF
Receives: Drug: rhG-CSF/PEG-rhG-CSF

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: At the end of Cycle 1 (21 days one cycle)

Secondary outcomes (9)

  1. Incidence of Febrile neutropenia(FN).

    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.

    Measured: Cycle1 to Cycle 4(21 days one cycle)

  2. Mean duration of DSN.

    Measured: Cycle2 to Cycle 4 (21 days one cycle)

  3. Incidence of Grade 3 neutropenia.

    Grade 3 neutropenia defines as the ANC count is less than 1.0×10^9 cells/L.

    Measured: Cycle1 to Cycle 4 ( 21 days one cycle)

  4. Mean duration of grade 3 neutropenia.

    Measured: Cycle1 to Cycle 4(21 days one cycle)

  5. Neutrophils dynamic changes from baseline.

    Measured: Cycle1 to Cycle 4 ( 21 days one cycle)

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

    Measured: Cycle1 to Cycle 4 (21 days one cycle)

  7. Proportion of patients with antibiotic usage.

    Measured: Cycle1 to Cycle 4 ( 21 days one cycle)

  8. Proportion of patients experienced infection.

    Measured: Cycle1 to Cycle 4 ( 21 days one cycle)

  9. Proportion of patients fulfilling expected chemotherapy.

    Measured: Cycle1 to Cycle 4 (21 days one cycle)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2020
  2. Study start16 Oct 2020
  3. Primary completion24 Jun 2021
  4. Study completion1 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
398 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04466137
Sponsor's protocol ID
TB1801CSF
Status last verified
Jan 2022
First submitted
29 Jun 2020
Last updated
9 Feb 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40098083

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing YPEG-rhG-CSF and rhG-CSF/PEG-rhG-CSF in people with Non-Myeloid Malignancy, run by Xiamen Amoytop Biotech Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Duration of Severe Neutropenia (DSN) During Cycle 1. (time frame: At the end of Cycle 1 (21 days one cycle)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04466137, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in