Skip to content

Outcomes of Early and Late Administration G-CSF for Primary Prophylaxis in Non-Hodgkin's Lymphoma Patients

A Comparison Outcomes of Early and Late Administration G-CSF for Primary Prophylaxis in Non-Hodgkin's Lymphoma Patients Who Receive Chemotherapy, Multicenter Study

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06665737
Acronym
G-CSF in NHL
Enrollment
126
Registered
2024-10-30
Start date
2025-02-01
Completion date
2026-12-31
Last updated
2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile Neutropenia (FN), Granulocyte Colony Stimulating Factor, Myelosuppression Adult, Non-Hodgkin's Lymphoma (NHL)

Keywords

Non-Hodgkin's lymphoma, Febrile neutropenia, Granulocyte Colony Stimulating Factor, Myelosuppression

Brief summary

The goal of this clinical trial is to Primary Objectives: 1. To compare the incidence of febrile neutropenia in patients with non-Hodgkin's lymphoma who received early or late granulocyte colony-stimulating factor (G-CSF) during standard chemotherapy in a multicenter study 2. To determine the incidence of leukopenia and neutropenia in patients with non-Hodgkin's lymphoma who received early or late G-CSF during standard chemotherapy in a multicenter study Secondary Objectives: 1. To determine changes in white blood cell, hemoglobin, and platelet levels in patients with non-Hodgkin's lymphoma who received early or late G-CSF during standard chemotherapy. 2. To determine the quality of life of patients with non-Hodgkin's lymphoma who undergoing standard chemotherapy and with neutropenia Researchers will compare the outcome between patients received either early G-CSF (within 72 hours) or late G-CSF (after 72 hours). All patients will be followed up to monitor for febrile neutropenia events, other hematological parameters and quality of life.

Detailed description

This study aims to analyze the impact of the timing of granulocyte colony-stimulating factor (G-CSF) administration on the prevention of febrile neutropenia (FN) in non-Hodgkin's lymphoma patients undergoing standard chemotherapy. G-CSF is a growth factor that stimulates the production of white blood cell in order to fighting infection. When non-Hodgkin's lymphoma patients receive chemotherapy for eradicating cancer cells. They also have collateral damage those white blood cells and other hematopoietic cell lines. All patients received standard chemotherapy regimens once every four weeks. The study will compare the efficacy of early G-CSF administration, or late administration, after each course of chemotherapy. The primary endpoint is the incidence of FN in each chemotherapy course. At the end of each chemotherapy course, patients received either early G-CSF (within 72 hours) or late G-CSF (after 72 hours). All patients will be followed up to monitor for FN events. Secondary endpoints include the incidence of myelosuppression and quality of life, assessed during outpatient and emergency department visits.

Interventions

DRUGEarly receiving G-CSF group

Early receiving G-CSF group will be given within 72 hours post chemotherapy

DRUGLate receiving G-CSF group

Late receiving G-CSF group will be given after 72 hours post chemotherapy

Sponsors

Mahidol University
CollaboratorOTHER
Internal Medicine Unit, Pranangklao Hospital
CollaboratorUNKNOWN
Department of Medical Services Ministry of Public Health of Thailand
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Group A: Early receiving G-CSF Group B: Late receiving G-CSF

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Aged 18 years or old * Confirmed lymphoma undergoing standard chemotherapy * Signed an approval informed consent * Has a good understanding of Thai * Available for follow-up after chemotherapy

Exclusion criteria

* Pregnancy or lactation * Serious concomitant diseases and discontinuous treatment such as cardiovascular, liver, or kidney diseases * Contraindication to chemotherapy or G-CSF administration * Antibiotic use within 1 week prior to enrollment

Design outcomes

Primary

MeasureTime frameDescription
Incidence of febrile neutropeniaOne yearIncidence of febrile neutropenia in each course
Incidence of leukopenia and neutropeniaOne yearIncidence of leukopenia and neutropenia in each course

Secondary

MeasureTime frameDescription
Incidence of grade 3 or 4 of myelosuppressionOne yearIncidence of 3 or 4 myelosuppression in each course
Time of visits to outpatient (OPD) and emergency clinics (ER)One yearIncidence of visit to OPD or ER in each course
Quality of life (QoL) after chemotherapyOne yearQuality of life score daily in each course

Countries

Thailand

Contacts

Primary ContactPraviwan Thungthong PT Rajavithi Hospital, M.D.
pthungthong@gmail.com+662-206-2900
Backup ContactSupat Chamnanchanunt SC Department of Clinical Tropical Medicine, Mahidol University, M.D.
supat.cha@mahidol.ac.th+662-354-9100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026