Clinical trial NCT06665737: Outcomes of Early and Late Administration G-CSF for Primary Prophylaxis in Non-Hodgkin's Lymphoma Patients
Official title: A Comparison Outcomes of Early and Late Administration G-CSF for Primary Prophylaxis in Non-Hodgkin's Lymphoma Patients Who Receive Chemotherapy, Multicenter Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Non-Hodgkin's Lymphoma (NHL)
Granulocyte Colony Stimulating Factor
Febrile Neutropenia (FN)
Myelosuppression Adult
Keywords: Non-Hodgkin&#39;s lymphoma
Febrile neutropenia
Granulocyte Colony Stimulating Factor
Myelosuppression
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
Collaborators: name: Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University
name: Internal Medicine Unit, Pranangklao Hospital
First posted: 2024-10-30
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A: Early receiving G-CSF Group B: Late receiving G-CSF
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of febrile neutropenia
timeFrame: One year
measure: Incidence of leukopenia and neutropenia
timeFrame: One year
Secondary outcomes:
measure: Incidence of grade 3 or 4 of myelosuppression
timeFrame: One year
measure: Time of visits to outpatient (OPD) and emergency clinics (ER)
timeFrame: One year
measure: Quality of life (QoL) after chemotherapy
timeFrame: One year
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Nontaburi
country: Thailand
facility: Internal Medicine Unit, Pranongklao Hospital
Study officials:
References: