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| ID | Type | Description | Link |
|---|---|---|---|
| Rajavithi Hospital | Other Grant/Funding Number | Rajavithi Hospital |
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| Name | Class |
|---|---|
| Mahidol University | OTHER |
| Internal Medicine Unit, Pranangklao Hospital | UNKNOWN |
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The goal of this clinical trial is to
Primary Objectives:
Secondary Objectives:
All patients will be followed up to monitor for febrile neutropenia events, other hematological parameters and quality of life.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early receiving G-CSF group | Active Comparator | Early receiving G-CSF group Patients in early receiving G-CSF group accept within 72 hours post chemotherapy |
|
| Late receiving G-CSF group | Placebo Comparator | Last receiving G-CSF group Patients in early receiving G-CSF group accept after 72 hours post chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early receiving G-CSF group | Drug | Early receiving G-CSF group will be given within 72 hours post chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of febrile neutropenia | Incidence of febrile neutropenia in each course | One year |
| Incidence of leukopenia and neutropenia | Incidence of leukopenia and neutropenia in each course | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grade 3 or 4 of myelosuppression | Incidence of 3 or 4 myelosuppression in each course | One year |
| Time of visits to outpatient (OPD) and emergency clinics (ER) | Incidence of visit to OPD or ER in each course |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Praviwan Thungthong PT Rajavithi Hospital, M.D. | Contact | +662-206-2900 | 10526 | pthungthong@gmail.com |
| Supat Chamnanchanunt SC Department of Clinical Tropical Medicine, Mahidol University, M.D. | Contact | +662-354-9100 | 2060 | supat.cha@mahidol.ac.th |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University | Bangkok | Bangkok | 10400 | Thailand | ||
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Group A: Early receiving G-CSF Group B: Late receiving G-CSF
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| Late receiving G-CSF group | Drug | Late receiving G-CSF group will be given after 72 hours post chemotherapy |
|
| One year |
| Quality of life (QoL) after chemotherapy | Quality of life score daily in each course | One year |
| Rajavithi Hospital |
| Bangkok |
| Bangkok |
| 10400 |
| Thailand |
| Internal Medicine Unit, Pranongklao Hospital | Nontaburi | Nontaburi | 11000 | Thailand |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D007960 | Leukocyte Disorders |
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