NCT04547829

Brief Summary

The purpose is to evaluate the safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy, and then evaluate the effectiveness of PEG-rhG-CSF in preventing neutropenia in children with tumor after chemotherapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
26 days until next milestone

Study Start

First participant enrolled

October 10, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2023

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

September 11, 2020

Last Update Submit

August 27, 2021

Conditions

Pediatric Cancer

Outcome Measures

Primary Outcomes (1)

  • safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy

    The incidence and severity of adverse events;

    From the beginning of observation to the end of observation（6 weeks) of the last enrolled patient

Secondary Outcomes (1)

  • To evaluate the effectiveness of PEG-rhG-CSF in preventing neutropenia in children with tumor after chemotherapy.

    From the beginning of observation to the end of observation（6 weeks) of the last enrolled patient

Study Arms (1)

PEG-rhG-CSF

EXPERIMENTAL

pegylated recombinant human granulocyte-colony stimulating factor subcutaneous injection

Drug: pegylated recombinant human granulocyte-colony stimulating factor

Interventions

pegylated recombinant human granulocyte-colony stimulating factorDRUG

The dosage was determined according to the patient's weight, 100 UG / kg each time; The method of administration: subcutaneous injection; The time of administration: 24-48 hours after the end of chemotherapy, once in each chemotherapy cycle.

PEG-rhG-CSF

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- 1)6 years \< age \< 18 years old, regardless of gender; 2)Tumor patients diagnosed by histopathology or bone marrow cytology; 3)Patients who have not been treated for the first time; 4)ECoG score ≤ 2; 5)The expected survival time is more than 8 months; 6)The hematopoietic function of bone marrow was normal (ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L, Hb ≥ 75 g / L, WBC ≥ 3.0 × 109 / L); 7)Receive high-intensity chemotherapy, such as scccg lymphoma, CAV / ie, VIP regimen, etc., and expect bone marrow suppression of grade III or above after chemotherapy.
  • )Patient's parent or guardian signs informed consent.

You may not qualify if:

  • Patients with any of the following items will not be enrolled in this study:
  • Local or systemic infection without adequate control;
  • Severe visceral dysfunction;
  • Liver function test: total bilirubin (TBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST) were all higher than 2.5 times of the upper limit of normal value; if due to liver metastasis, the above indicators were more than 5 times of the upper limit of normal value; renal function test: Serum creatinine (CR) \> 2 times of the upper limit of normal value;
  • Those who took the same kind of other tested drugs or accepted clinical trials of other drugs within 4 weeks before enrollment;
  • Allergic to peg-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
  • Serious mental illness, affecting informed consent and / or expression or observation of adverse reactions;
  • The researcher judged the patients who were not suitable to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center,

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (1)

  • Huang J, Lu S, Wang J, Jiang L, Luo X, He X, Wu Y, Wang Y, Zhu X, Chen J, Tang Y, Chen K, Tian X, Shi B, Guo L, Zhu J, Sun F, Zhen Z, Zhang Y. A multicenter phase II trial of primary prophylactic PEG-rhG-CSF in pediatric patients with solid tumors and non-Hodgkin lymphoma after chemotherapy: An interim analysis. Cancer Med. 2023 Jul;12(13):14130-14137. doi: 10.1002/cam4.6079. Epub 2023 May 15.

    PMID: 37183837DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Yizhuo Zhang

    Sun Yat-sen University CancerCenter

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yizhuo Zhang

CONTACT

020-87342459zhangyzh@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sun Yat-sen University Cancer Center

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 14, 2020

Study Start

October 10, 2020

Primary Completion

October 10, 2022

Study Completion

May 10, 2023

Last Updated

September 2, 2021

Record last verified: 2021-08

Locations

CN(1)