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Trial Title:
Outcomes of Early and Late Administration G-CSF for Primary Prophylaxis in Non-Hodgkin's Lymphoma Patients
NCT ID:
NCT06665737
Condition:
Non-Hodgkin's Lymphoma (NHL)
Granulocyte Colony Stimulating Factor
Febrile Neutropenia (FN)
Myelosuppression Adult
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neutropenia
Febrile Neutropenia
Lenograstim
Conditions: Keywords:
Non-Hodgkin's lymphoma
Febrile neutropenia
Granulocyte Colony Stimulating Factor
Myelosuppression
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Group A: Early receiving G-CSF Group B: Late receiving G-CSF
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Early receiving G-CSF group
Description:
Early receiving G-CSF group will be given within 72 hours post chemotherapy
Arm group label:
Early receiving G-CSF group
Intervention type:
Drug
Intervention name:
Late receiving G-CSF group
Description:
Late receiving G-CSF group will be given after 72 hours post chemotherapy
Arm group label:
Late receiving G-CSF group
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University
Address:
City:
Bangkok
Zip:
10400
Country:
Thailand
Facility:
Name:
Rajavithi Hospital
Address:
City:
Bangkok
Zip:
10400
Country:
Thailand
Facility:
Name:
Internal Medicine Unit, Pranongklao Hospital
Address:
City:
Nontaburi
Zip:
11000
Country:
Thailand
Start date:
December 1, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Rajavithi Hospital
Agency class:
Other
Collaborator:
Agency:
Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University
Agency class:
Other
Collaborator:
Agency:
Internal Medicine Unit, Pranangklao Hospital
Agency class:
Other
Source:
Rajavithi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06665737
