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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorDepartment of Medical Services Ministry of Public Health of Thailand

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or old

Confirmed lymphoma undergoing standard chemotherapy

Signed an approval informed consent

Has a good understanding of Thai

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Early receiving G-CSF groupActive comparator 1 intervention
Group B: Late receiving G-CSF groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of febrile neutropenia

Incidence of febrile neutropenia in each course

Time frame
One year
2

Incidence of leukopenia and neutropenia

Incidence of leukopenia and neutropenia in each course

Time frame
One year

Secondary outcomes

1

Incidence of grade 3 or 4 of myelosuppression

Incidence of 3 or 4 myelosuppression in each course

Time frame
One year
2

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

Incidence of visit to OPD or ER in each course

Time frame
One year
3

Quality of life (QoL) after chemotherapy

Quality of life score daily in each course

Time frame
One year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Department of Medical Services Ministry of Public Health of Thailand

Lead sponsor

Mahidol University

Collaborator

Internal Medicine Unit, Pranangklao Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: