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

NCT ID: NCT06665737

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Early receiving G-CSF group

Early receiving G-CSF group Patients in early receiving G-CSF group accept within 72 hours post chemotherapy

Group Type: ACTIVE_COMPARATOR

Early receiving G-CSF group

Intervention Type: DRUG

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

Late receiving G-CSF group

Last receiving G-CSF group Patients in early receiving G-CSF group accept after 72 hours post chemotherapy

Group Type: PLACEBO_COMPARATOR

Late receiving G-CSF group

Intervention Type: DRUG

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

Interventions

Early receiving G-CSF group

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

Intervention Type: DRUG

Late receiving G-CSF group

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: collaborator

Internal Medicine Unit, Pranangklao Hospital

UNKNOWN

Sponsor Role: collaborator

Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Bangkok, Bangkok, Thailand

Rajavithi Hospital

Bangkok, Bangkok, Thailand

Internal Medicine Unit, Pranongklao Hospital

Nontaburi, Nontaburi, Thailand

Countries

Thailand

Central Contacts

Praviwan Thungthong PT Rajavithi Hospital, M.D.

Role: CONTACT

pthungthong@gmail.com

+662-206-2900 ext. 10526

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

Role: CONTACT

supat.cha@mahidol.ac.th

+662-354-9100 ext. 2060

Other Identifiers

Rajavithi Hospital

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

205/2567

Identifier Type: -

Identifier Source: org_study_id