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

Phase 4

Not yet recruiting

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

Interventions: Drug: Early receiving G-CSF group
Drug: Late receiving G-CSF group

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Early receiving G-CSF group	Early receiving G-CSF group	Early receiving G-CSF group Patients in early receiving G-CSF group accept within 72 hours post chemotherapy
Late receiving G-CSF group	Late receiving G-CSF group	Last receiving G-CSF group Patients in early receiving G-CSF group accept after 72 hours post chemotherapy

Primary Outcome Measures

Name	Time	Method
Incidence of febrile neutropenia	One year	Incidence of febrile neutropenia in each course
Incidence of leukopenia and neutropenia	One year	Incidence of leukopenia and neutropenia in each course

Secondary Outcome Measures

Name	Time	Method
Incidence of grade 3 or 4 of myelosuppression	One year	Incidence of 3 or 4 myelosuppression in each course
Time of visits to outpatient (OPD) and emergency clinics (ER)	One year	Incidence of visit to OPD or ER in each course
Quality of life (QoL) after chemotherapy	One year	Quality of life score daily in each course

Locations (3): Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University
🇹🇭
Bangkok, Thailand
Rajavithi Hospital
🇹🇭
Bangkok, Thailand
Internal Medicine Unit, Pranongklao Hospital
🇹🇭
Nontaburi, Thailand