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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Early receiving G-CSF group
DrugEarly receiving G-CSF group will be given within 72 hours post chemotherapy
Late receiving G-CSF group
DrugLate receiving G-CSF group will be given after 72 hours post chemotherapy
Treatment groups
Trial outcomes
Primary outcomes
Incidence of febrile neutropenia
Incidence of febrile neutropenia in each course
Incidence of leukopenia and neutropenia
Incidence of leukopenia and neutropenia in each course
Secondary outcomes
Incidence of grade 3 or 4 of myelosuppression
Incidence of 3 or 4 myelosuppression in each course
Time of visits to outpatient (OPD) and emergency clinics (ER)
Incidence of visit to OPD or ER in each course
Quality of life (QoL) after chemotherapy
Quality of life score daily in each course
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: