Outcomes of Early and Late Administration G-CSF for Primary Prophylaxis in Non-Hodgkin's Lymphoma Patients
NCT06665737 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 126
Last updated 2025-01-28
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.
Conditions
- Non-Hodgkin's Lymphoma (NHL)
- Granulocyte Colony Stimulating Factor
- Febrile Neutropenia (FN)
- Myelosuppression Adult
Interventions
- 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
Sponsors & Collaborators
-
Mahidol University
collaborator OTHER -
Internal Medicine Unit, Pranangklao Hospital
collaborator UNKNOWN -
Department of Medical Services Ministry of Public Health of Thailand
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-01
- Primary Completion
- 2026-02-27
- Completion
- 2026-12-31
Countries
- Thailand
Study Locations
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