Non-Hodgkin's Lymphoma (NHL)Phase 4G-CSF in NHLNCT06665737
Outcomes of Early and Late Administration G-CSF for Primary Prophylaxis in Non-Hodgkin's Lymphoma Patients
A Phase 4 study testing Early receiving G-CSF group and Late receiving G-CSF group in people with Non-Hodgkin's Lymphoma (NHL) and Granulocyte Colony Stimulating Factor, run by Department of Medical Services Ministry of Public Health of Thailand at 3 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma (NHL), Granulocyte Colony Stimulating Factor, Febrile Neutropenia (FN)
- What is being tested?
- Early receiving G-CSF group and Late receiving G-CSF group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 3 sitesThailand
- Study dates
- 1 Feb 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Praviwan Thungthong PT Rajavithi Hospital, M.D. contact
Supat Chamnanchanunt SC Department of Clinical Tropical Medicine, Mahidol University, M.D. contact
Thailand3 sites
Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University
Bangkok, Bangkok, 10400
Rajavithi Hospital
Bangkok, Bangkok, 10400
Internal Medicine Unit, Pranongklao Hospital
Nontaburi, Nontaburi, 11000
About this study
Official title: A Comparison Outcomes of Early and Late Administration G-CSF for Primary Prophylaxis in Non-Hodgkin's Lymphoma Patients Who Receive Chemotherapy, Multicenter Study
The goal of this clinical trial is to
Primary Objectives:
Read more
- 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
- 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:
- 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.
- 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.
Read the 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
- Being tested
- Early receiving G-CSF group, Late receiving G-CSF group
- Keywords
- Non-Hodgkin's lymphoma, Febrile neutropenia, Granulocyte Colony Stimulating Factor, Myelosuppression
- Medical subject headings
- Lymphoma, Non-Hodgkin, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early receiving G-CSF groupDrug
Early receiving G-CSF group will be given within 72 hours post chemotherapy
Late receiving G-CSF groupDrug
Late receiving G-CSF group will be given after 72 hours post chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Early receiving G-CSF group |
| 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 Receives: Drug: Late receiving G-CSF group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of febrile neutropenia
Incidence of febrile neutropenia in each course
Measured: One year
Incidence of leukopenia and neutropenia
Incidence of leukopenia and neutropenia in each course
Measured: One year
Secondary outcomes (3)
Incidence of grade 3 or 4 of myelosuppression
Incidence of 3 or 4 myelosuppression in each course
Measured: One year
Time of visits to outpatient (OPD) and emergency clinics (ER)
Incidence of visit to OPD or ER in each course
Measured: One year
Quality of life (QoL) after chemotherapy
Quality of life score daily in each course
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Feb 2025 (estimated)
- Primary completion27 Feb 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's Lymphoma (NHL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A: Early receiving G-CSF Group B: Late receiving G-CSF
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Collaborators
- Mahidol University, Internal Medicine Unit, Pranangklao Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665737
- Sponsor's protocol ID
- 205/2567
- Other IDs
- Rajavithi Hospital
- Acronym
- G-CSF in NHL
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Outcomes of Early and Late Administration G-CSF for Primary Prophylaxis in Non-Hodgkin's Lymphoma Patients Who Receive Chemotherapy, Multicenter Study
- ClinicalTrials.gov ID
- NCT06665737
- Acronym / sponsor ID
- G-CSF in NHL / 205/2567
- Conditions
- Non-Hodgkin's Lymphoma (NHL), Granulocyte Colony Stimulating Factor, Febrile Neutropenia (FN), Myelosuppression Adult
- Keywords
- Non-Hodgkin's lymphoma, Febrile neutropenia, Granulocyte Colony Stimulating Factor, Myelosuppression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Collaborators
- Mahidol University, Internal Medicine Unit, Pranangklao Hospital
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 27 Feb 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to
Primary Objectives:
- 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
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A: Early receiving G-CSF Group B: Late receiving G-CSF
| Arm | Type | Receives |
|---|---|---|
| Early receiving G-CSF group | Active comparator | Drug: Early receiving G-CSF groupEarly receiving G-CSF group Patients in early receiving G-CSF group accept within 72 hours post chemotherapy |
| Late receiving G-CSF group | Placebo comparator | Drug: Late receiving G-CSF groupLast receiving G-CSF group Patients in early receiving G-CSF group accept after 72 hours post chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early receiving G-CSF groupEarly receiving G-CSF group will be given within 72 hours post chemotherapy | Drug | Early receiving G-CSF group |
| Late receiving G-CSF groupLate receiving G-CSF group will be given after 72 hours post chemotherapy | Drug | Late receiving G-CSF group |
Primary outcome
Incidence of febrile neutropenia
Time frame: One year
Incidence of febrile neutropenia in each course
Incidence of leukopenia and neutropenia
Time frame: One year
Incidence of leukopenia and neutropenia in each course
3 secondary outcomes
Incidence of grade 3 or 4 of myelosuppression
Time frame: One year
Time of visits to outpatient (OPD) and emergency clinics (ER)
Time frame: One year
Quality of life (QoL) after chemotherapy
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Non-Hodgkin's Lymphoma (NHL)
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Praviwan Thungthong PT Rajavithi Hospital, M.D. contact
Supat Chamnanchanunt SC Department of Clinical Tropical Medicine, Mahidol University, M.D. contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Early receiving G-CSF group and Late receiving G-CSF group in people with Non-Hodgkin's Lymphoma (NHL) and Granulocyte Colony Stimulating Factor, run by Department of Medical Services Ministry of Public Health of Thailand at 3 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Praviwan Thungthong PT Rajavithi Hospital, M.D. (+662-206-2900 ext. 10526, pthungthong@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of febrile neutropenia (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.