NCT06665737

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Department of Medical Services Ministry of Public Health of Thailand · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Early receiving G-CSF group	Early receiving G-CSF group will be given within 72 hours post chemotherapy
DRUG	Late receiving G-CSF group	Late receiving G-CSF group will be given after 72 hours post chemotherapy

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-02-27
• Completion: 2026-12-31
• First posted: 2024-10-30
• Last updated: 2025-01-28

Locations

3 sites across 1 country: Thailand