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

Rajavithi Hospital

Status and phase: Not yet enrolling; Phase 4

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

Treatments: Drug: Early receiving G-CSF group; Drug: Late receiving G-CSF group

Study type: Interventional

Funder types: Other

Identifiers

NCT06665737

205/2567

Rajavithi Hospital

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups, including a placebo group

Early receiving G-CSF group

Active Comparator group

Description:

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

Treatment:

Drug: Early receiving G-CSF group

Late receiving G-CSF group

Placebo Comparator group

Description:

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

Treatment:

Drug: Late receiving G-CSF group