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Not yet recruiting NCT06665737

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early receiving G-CSF group, Late receiving G-CSF group.
Who it may be relevant to
Registry conditions: Non-Hodgkin's Lymphoma (NHL), Granulocyte Colony Stimulating Factor, Febrile Neutropenia (FN), Myelosuppression Adult. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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

Primary outcome measures

  • Incidence of febrile neutropenia [Time frame: One year]
  • Incidence of leukopenia and neutropenia [Time frame: One year]
Secondary outcome measures (3)
  • Incidence of grade 3 or 4 of myelosuppression [Time frame: One year]
  • Time of visits to outpatient (OPD) and emergency clinics (ER) [Time frame: One year]
  • Quality of life (QoL) after chemotherapy [Time frame: One year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Thailand · 3 centers
  • Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University — Bangkok
  • Rajavithi Hospital — Bangkok
  • Internal Medicine Unit, Pranongklao Hospital — Nontaburi

Identifiers

NCT: NCT06665737 · 205/2567 · Rajavithi Hospital

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗