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NCT Number: NCT06665737

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early receiving G-CSF group

Drug

Early receiving G-CSF group will be given within 72 hours post chemotherapy

Late receiving G-CSF group

Drug

Late receiving G-CSF group will be given after 72 hours post chemotherapy

Primary outcomes

  1. Incidence of febrile neutropenia

    Time frame: One year

    Incidence of febrile neutropenia in each course

  2. Incidence of leukopenia and neutropenia

    Time frame: One year

    Incidence of leukopenia and neutropenia in each course

Secondary outcomes

  1. Incidence of grade 3 or 4 of myelosuppression

    Time frame: One year

    Incidence of 3 or 4 myelosuppression in each course

  2. Time of visits to outpatient (OPD) and emergency clinics (ER)

    Time frame: One year

    Incidence of visit to OPD or ER in each course

  3. Quality of life (QoL) after chemotherapy

    Time frame: One year

    Quality of life score daily in each course

Study contacts

Contact information is provided by the study sponsor or research team.

Praviwan Thungthong PT Rajavithi Hospital, M.D.

CONTACT

[email protected]

+662-206-2900 ext. 10526

Supat Chamnanchanunt SC Department of Clinical Tropical Medicine, Mahidol University, M.D.

CONTACT

[email protected]

+662-354-9100 ext. 2060

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Collaborators

  • Internal Medicine Unit, Pranangklao Hospital
  • Mahidol University

Registry information

Official study 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

Acronym: G-CSF in NHL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 30, 2024
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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