NCT03498248

Brief Summary

The purpose of this study was to analyze the clinical factors associated with the effect of Granulocyte-Colony Stimulating Factor (G-CSF).

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
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

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

Study Start

First participant enrolled

February 19, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

April 13, 2018

Status Verified

April 1, 2018

Enrollment Period

6 months

First QC Date

April 7, 2018

Last Update Submit

April 7, 2018

Conditions

Neutropenia

Outcome Measures

Primary Outcomes (1)

  • duration of severe neutropenia

    count days of neutrophils increased above 1,000

    at least in 1 wk

Study Arms (1)

Neutropenia in chemotherapy

EXPERIMENTAL

Neutropenia after cytotoxic chemotherapy

Drug: lenograstim

Interventions

lenograstimDRUG

injection of lenograstim in patients with neutropenia after cytotoxic chemotherapy

Neutropenia in chemotherapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with solid cancer and blood cancer
  • Patients who received chemotherapy with moderate risk (Appendix 1, Appendix 2)
  • CTCAE version 4.0 showed grade 4 neutropenia, grade 3 neutropenia (blood cancer), Decreased grade 3 neutrophils with fever (solid cancer)
  • Those who understand and agree with the purpose of the research

You may not qualify if:

  • \) Patients with hypersensitivity to G-CSF 2) Patients not diagnosed with hematologic tumor 3) grade 1, grade 2 or more neutropenia 4) Patients who did not sign a consent agreement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Catholic university of Korea

Seoul, Gyounggido, 480-130, South Korea

RECRUITING

MeSH Terms

Conditions

Neutropenia

Interventions

Lenograstim

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Yoon Ho Ko

    Uijeongbu St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

DER SHENG SUN

CONTACT

318203584sundersheng@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: neutropenia after cytotoxic chemotherapy
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Associated Professor

Study Record Dates

First Submitted

April 7, 2018

First Posted

April 13, 2018

Study Start

February 19, 2018

Primary Completion

August 31, 2018

Study Completion

August 31, 2019

Last Updated

April 13, 2018

Record last verified: 2018-04

Locations

KR(1)