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

A Comparison Outcomes of Early and Late Administration G-CSF for Primary Prophylaxis in Non-Hodgkin's Lymphoma Patients Who Receive Chemotherapy, Multicenter Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-Hodgkin's Lymphoma (NHL); Myelosuppression Adult; Febrile Neutropenia (FN); Granulocyte Colony Stimulating Factor
• Intervention / Treatment: Drug: Early receiving G-CSF group; Drug: Late receiving G-CSF group

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.

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Praviwan Thungthong PT Rajavithi Hospital, M.D.; Phone Number: 10526 +662-206-2900; Email: pthungthong@gmail.com
• Study Contact Backup: Name: Supat Chamnanchanunt SC Department of Clinical Tropical Medicine, Mahidol University, M.D.; Phone Number: 2060 +662-354-9100; Email: supat.cha@mahidol.ac.th

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital
  • Bangkok, Thailand, 10400
    • Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University
  • Nontaburi, Thailand, 11000
    • Internal Medicine Unit, Pranongklao Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early receiving G-CSF group; Early receiving G-CSF group Patients in early receiving G-CSF group accept within 72 hours post chemotherapy	Drug: Early receiving G-CSF group; Early receiving G-CSF group will be given within 72 hours post chemotherapy
Placebo Comparator: Late receiving G-CSF group; Last receiving G-CSF group Patients in early receiving G-CSF group accept after 72 hours post chemotherapy	Drug: Late receiving G-CSF group; Late receiving G-CSF group will be given after 72 hours post chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of febrile neutropenia	Incidence of febrile neutropenia in each course	One year
Incidence of leukopenia and neutropenia	Incidence of leukopenia and neutropenia in each course	One year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rajavithi Hospital
• Collaborators: Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University; Internal Medicine Unit, Pranangklao Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): February 27, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: October 29, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Non-Hodgkin's lymphoma; Febrile neutropenia; Granulocyte Colony Stimulating Factor; Myelosuppression
• Additional Relevant MeSH Terms: Cytopenia; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Leukocyte Disorders; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukopenia; Agranulocytosis; Lymphoma; Lymphoma, Non-Hodgkin; Neutropenia; Febrile Neutropenia; Immunologic Factors; Physiological Effects of Drugs; Adjuvants, Immunologic; Lenograstim
• Other Study ID Numbers: 205/2567; Rajavithi Hospital (Other Grant/Funding Number: Rajavithi Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No