Graft-Versus-Host Disease(GVHD)Phase 1/2NCT07162688
Effects of Omega-3 Fatty Acids on Acute Graft-versus-Host Disease After Allogeneic Stem Cell Transplantation.
A Phase 1/2 study testing Omega-3 Lipid Emulsion in people with Graft-Versus-Host Disease(GVHD), run by Fujian Medical University at 1 site in China.
Trial summary
Study Title: A Study on the Effects and Mechanisms of Omega-3 Polyunsaturated Fatty Acids on Acute Graft-Versus-Host Disease (aGVHD) Following Allogeneic Hematopoietic Stem Cell Transplantation Study Type: Open-label, randomized, single-center proof-of-concept clinical trial Objective: To evaluate the immunomodulatory… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Graft-Versus-Host Disease(GVHD)
- What is being tested?
- Omega-3 Lipid Emulsion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2025to 15 Jun 2028
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT)
- Age 18 to 65 years (inclusive)
- Male or female
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3
- Expected survival of at least 100 days
- Willingness to participate and provide written informed consent
Who cannot join
- History of solid organ transplantation
- Serum triglycerides ≥ 7.9 mmol/L
- Uncontrolled diabetes
- Severe dyslipidemia (e.g., LDL-C ≥ 4.9 mmol/L)
- Contraindications to parenteral nutrition (e.g., severe electrolyte imbalance, acidosis)
- Severe hepatic impairment (AST/ALT > 3× ULN)
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- Creatinine clearance < 15 mL/min
- Known allergy to Omega-3, fish, or egg protein
- Significant psychiatric illness or substance abuse interfering with study compliance
- Participation in another clinical trial or receipt of other experimental treatments during the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 353000
About this study
Official title: Effects and Mechanism of Omega-3 Polyunsaturated Fatty Acids on Acute Graft-versus-host Disease (aGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation
Study Title:
A Study on the Effects and Mechanisms of Omega-3 Polyunsaturated Fatty Acids on Acute Graft-Versus-Host Disease (aGVHD) Following Allogeneic Hematopoietic Stem Cell Transplantation
Read more
Study Type:
Open-label, randomized, single-center proof-of-concept clinical trial
Objective:
To evaluate the immunomodulatory and metabolic effects of Omega-3 polyunsaturated fatty acids (PUFAs) in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT), and to explore their potential in preventing and mitigating acute graft-versus-host disease (aGVHD).
Study Population:
More than 30 patients aged 18-65 years undergoing allo-HSCT.
Intervention:
Daily intravenous infusion of Omega-3 lipid emulsion at 2 mL/kg (equivalent to 0.2 g/kg of fish oil), administered in combination with medium/long-chain fat emulsion, starting from the conditioning regimen until neutrophil and platelet engraftment or up to Day +35.
Primary Endpoint:
Incidence and severity of aGVHD within 100 days post-transplant.
Secondary Endpoints:
Immune reconstitution (changes in T, B, and NK cell subsets) Lipid and metabolic regulation (TC, TG, HDL-C, LDL-C, TBA) Incidence and severity of infections Overall survival (OS) and progression-free survival (PFS)
Statistical Analysis:
Chi-square/Fisher's exact test, Kaplan-Meier survival analysis with log-rank test, multivariate regression, metabolomics and transcriptomics (PCA, PLS-DA), and pathway enrichment and correlation analyses.
Expected Outcome:
Omega-3 supplementation is expected to reduce the incidence and severity of aGVHD by modulating immune responses and metabolic processes, thereby providing a novel preventive strategy for post-transplant complications.
Read the detailed description
This study evaluates the therapeutic potential of Omega-3 polyunsaturated fatty acids (PUFAs) in the context of acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Omega-3 fatty acids have demonstrated beneficial effects on cardiovascular health, regulation of immune responses, and modulation of inflammatory pathways. Given that current immunosuppressive therapies for aGVHD are often associated with significant side effects and limited efficacy, the development of safer and more effective interventions is urgently needed.
The investigators have previously established robust research platforms, including HTLV-1 detection methods, infection and disease models (such as humanized mice and Diannan small-eared pig models), as well as multi-omics technologies covering virology, immunology, genomics, and epigenetics. Building on this foundation, the present trial aims to:
Conduct integrative analyses of viral genomic characteristics and host genetic susceptibility to construct a risk prediction model for ATL development, providing data support for clinical prevention and treatment strategies.
Characterize the dynamic spatial and temporal changes of the host immune microenvironment at the single-cell level after HTLV-1 infection, and elucidate key nodes of virus-host interaction that contribute to aGVHD pathogenesis.
Establish and optimize therapeutic strategies targeting the NPM1/B23-sHBZ interaction, and evaluate the specificity, efficacy, and safety of Omega-3 PUFA-based immunotherapy alone or in combination with agents such as PD-1 antibodies, chidamide, and DNA methyltransferase inhibitors.
Assess treatment outcomes by monitoring virological suppression, tumor burden, immune and metabolic microenvironment alterations, epigenetic modifications, incidence and severity of cytokine release syndrome (CRS), hematological parameters, and overall survival.
This proof-of-concept study is expected to provide important scientific evidence for the development of novel immunotherapy approaches targeting ATL, with the potential to improve prognosis and expand therapeutic options for patients undergoing allo-HSCT.
- Conditions
- Graft-Versus-Host Disease(GVHD)
- Being tested
- Omega-3 Lipid Emulsion
- Keywords
- Allogeneic Hematopoietic Stem Cell Transplantation, Acute Graft-versus-Host Disease, Immunomodulation
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Lipid EmulsionDrug
Also called ω-3 Lipid Emulsion, Omega-3 PUFA, Omega-3 Fatty Acid Emulsion
Intravenous Omega-3 lipid emulsion administered at a dose of 2 mL/kg/day (equivalent to 0.2 g/kg of fish oil), starting from the conditioning phase prior to hematopoietic stem cell infusion and continuing daily until neutrophil and platelet engraftment or up to Day +35 post-transplantation. The emulsion is infused over 4-6 hours and combined with medium- and long-chain triglyceride emulsion as part of parenteral nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 Lipid Emulsion Group | Experimental | Participants in this arm will receive standard post-transplant care plus intravenous Omega-3 lipid emulsion at a dose of 2 mL/kg/day (equivalent to 0.2 g/kg of fish oil). The infusion will begin during the conditioning phase and continue daily until neutrophil and platelet engraftment or up to Day +35 post-transplantation. Receives: Drug: Omega-3 Lipid Emulsion |
| No Intervention | No intervention | Participants in this arm will receive standard post-transplant care as per institutional protocol. No Omega-3 lipid emulsion or additional investigational product will be administered. This group serves as the control group for evaluating the effects of Omega-3 supplementation in the experimental arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Acute Graft-versus-Host Disease (aGVHD) Within 100 Days After Allogeneic Hematopoietic Stem Cell Transplantation
The primary outcome is to assess the incidence and clinical severity of acute graft-versus-host disease (aGVHD) occurring within 100 days following allogeneic hematopoietic stem cell transplantation. aGVHD will be diagnosed and graded based on standard clinical criteria involving skin, liver, and gastrointestinal tract involvement, using established staging and grading systems.
Measured: Within 100 days post-transplantation
Secondary outcomes (1)
Progression-Free Survival (PFS) at Day 100 Post-Transplantation
Progression-Free Survival (PFS) is defined as the time from transplantation to disease relapse, progression, or death from any cause, whichever occurs first. Participants who are alive and without disease progression at Day 100 will be considered progression-free.
Measured: 100 days post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start16 May 2025
- Primary completion7 Mar 2028 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft-Versus-Host Disease(GVHD)Studies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, open-label, randomized, parallel assignment trial. Participants undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) will be randomly assigned in a 1:1 ratio to either receive standard care or standard care plus intravenous Omega-3 lipid emulsion. The intervention will continue until hematopoietic engraftment or up to Day +35 post-transplantation. The primary objective is to assess the effect of Omega-3 supplementation on the incidence and severity of acute graft-versus-host disease (aGVHD) within 100 days post-transplant.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting YANG, Fujian Medical University
- Investigators
- Ting Yang, MD, PhD, Principal investigator, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162688
- Sponsor's protocol ID
- Omega3-aGVHD-01
- Other IDs
- In-hospital project fund
- Status last verified
- Nov 2025
- First submitted
- 26 May 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the exploratory nature of the study, limited sample size, and institutional data protection policies. Additionally, privacy concerns and ethical constraints prevent the public release of sensitive patient-level data.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanism of Omega-3 Polyunsaturated Fatty Acids on Acute Graft-versus-host Disease (aGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07162688
- Acronym / sponsor ID
- Omega3-aGVHD-01
- Conditions
- Graft-Versus-Host Disease(GVHD)
- Keywords
- Allogeneic Hematopoietic Stem Cell Transplantation, Acute Graft-versus-Host Disease, Immunomodulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 16 May 2025 (actual)
- Primary completion
- 7 Mar 2028 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 9 Sep 2025 (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.
Study Title:
A Study on the Effects and Mechanisms of Omega-3 Polyunsaturated Fatty Acids on Acute Graft-Versus-Host Disease (aGVHD) Following Allogeneic Hematopoietic Stem Cell Transplantation
Study Type:
Open-label, randomized, single-center proof-of-concept clinical trial
Objective:
To evaluate the immunomodulatory and metabolic effects of Omega-3 polyunsaturated fatty acids (PUFAs) in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT), and to explore their potential in preventing and mitigating acute graft-versus-host disease (aGVHD).
Study Population:
More than 30 patients aged 18-65 years undergoing allo-HSCT.
Intervention:
Daily intravenous infusion of Omega-3 lipid emulsion at 2 mL/kg (equivalent to 0.2 g/kg of fish oil), administered in combination with medium/long-chain fat emulsion, starting from the conditioning regimen until neutrophil and platelet engraftment or up to Day +35.
Primary Endpoint:
Incidence and severity of aGVHD within 100 days post-transplant.
Secondary Endpoints:
Immune reconstitution (changes in T, B, and NK cell subsets) Lipid and metabolic regulation (TC, TG, HDL-C, LDL-C, TBA) Incidence and severity of infections Overall survival (OS) and progression-free survival (PFS)
Statistical Analysis:
Chi-square/Fisher's exact test, Kaplan-Meier survival analysis with log-rank test, multivariate regression, metabolomics and transcriptomics (PCA, PLS-DA), and pathway enrichment and correlation analyses.
Expected Outcome:
Omega-3 supplementation is expected to reduce the incidence and severity of aGVHD by modulating immune responses and metabolic processes, thereby providing a novel preventive strategy for post-transplant complications.
Detailed description
This study evaluates the therapeutic potential of Omega-3 polyunsaturated fatty acids (PUFAs) in the context of acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Omega-3 fatty acids have demonstrated beneficial effects on cardiovascular health, regulation of immune responses, and modulation of inflammatory pathways. Given that current immunosuppressive therapies for aGVHD are often associated with significant side effects and limited efficacy, the development of safer and more effective interventions is urgently needed.
The investigators have previously established robust research platforms, including HTLV-1 detection methods, infection and disease models (such as humanized mice and Diannan small-eared pig models), as well as multi-omics technologies covering virology, immunology, genomics, and epigenetics. Building on this foundation, the present trial aims to:
Conduct integrative analyses of viral genomic characteristics and host genetic susceptibility to construct a risk prediction model for ATL development, providing data support for clinical prevention and treatment strategies.
Characterize the dynamic spatial and temporal changes of the host immune microenvironment at the single-cell level after HTLV-1 infection, and elucidate key nodes of virus-host interaction that contribute to aGVHD pathogenesis.
Establish and optimize therapeutic strategies targeting the NPM1/B23-sHBZ interaction, and evaluate the specificity, efficacy, and safety of Omega-3 PUFA-based immunotherapy alone or in combination with agents such as PD-1 antibodies, chidamide, and DNA methyltransferase inhibitors.
Assess treatment outcomes by monitoring virological suppression, tumor burden, immune and metabolic microenvironment alterations, epigenetic modifications, incidence and severity of cytokine release syndrome (CRS), hematological parameters, and overall survival.
This proof-of-concept study is expected to provide important scientific evidence for the development of novel immunotherapy approaches targeting ATL, with the potential to improve prognosis and expand therapeutic options for patients undergoing allo-HSCT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-center, open-label, randomized, parallel assignment trial. Participants undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) will be randomly assigned in a 1:1 ratio to either receive standard care or standard care plus intravenous Omega-3 lipid emulsion. The intervention will continue until hematopoietic engraftment or up to Day +35 post-transplantation. The primary objective is to assess the effect of Omega-3 supplementation on the incidence and severity of acute graft-versus-host disease (aGVHD) within 100 days post-transplant.
| Arm | Type | Receives |
|---|---|---|
| Omega-3 Lipid Emulsion Group | Experimental | Drug: Omega-3 Lipid EmulsionParticipants in this arm will receive standard post-transplant care plus intravenous Omega-3 lipid emulsion at a dose of 2 mL/kg/day (equivalent to 0.2 g/kg of fish oil). The infusion will begin during the conditioning phase and continue daily until neutrophil and platelet engraftment or up to Day +35 post-transplantation. |
| No Intervention | No intervention | –Participants in this arm will receive standard post-transplant care as per institutional protocol. No Omega-3 lipid emulsion or additional investigational product will be administered. This group serves as the control group for evaluating the effects of Omega-3 supplementation in the experimental arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT)
- Age 18 to 65 years (inclusive)
- Male or female
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3
- Expected survival of at least 100 days
Key exclusion criteria (10 listed)
- History of solid organ transplantation
- Serum triglycerides ≥ 7.9 mmol/L
- Uncontrolled diabetes
- Severe dyslipidemia (e.g., LDL-C ≥ 4.9 mmol/L)
- Contraindications to parenteral nutrition (e.g., severe electrolyte imbalance, acidosis)
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 |
|---|---|---|
| Omega-3 Lipid EmulsionAlso: ω-3 Lipid Emulsion, Omega-3 PUFA, Omega-3 Fatty Acid EmulsionIntravenous Omega-3 lipid emulsion administered at a dose of 2 mL/kg/day (equivalent to 0.2 g/kg of fish oil), starting from the conditioning phase prior to hematopoietic stem cell infusion and continuing daily until neutrophil and platelet engraftment or up to Day +35 post-transplantation. The emulsion is infused over 4-6 hours and combined with medium- and long-chain triglyceride emulsion as part of parenteral nutrition. | Drug | Omega-3 Lipid Emulsion Group |
Primary outcome
Incidence and Severity of Acute Graft-versus-Host Disease (aGVHD) Within 100 Days After Allogeneic Hematopoietic Stem Cell Transplantation
Time frame: Within 100 days post-transplantation
The primary outcome is to assess the incidence and clinical severity of acute graft-versus-host disease (aGVHD) occurring within 100 days following allogeneic hematopoietic stem cell transplantation. aGVHD will be diagnosed and graded based on standard clinical criteria involving skin, liver, and gastrointestinal tract involvement, using established staging and grading systems.
1 secondary outcome
Progression-Free Survival (PFS) at Day 100 Post-Transplantation
Time frame: 100 days post-transplantation
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 18 Nov 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the exploratory nature of the study, limited sample size, and institutional data protection policies. Additionally, privacy concerns and ethical constraints prevent the public release of sensitive patient-level data.
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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.
Ting Yang, MD, PhD principal investigator
First Affiliated Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Omega-3 Lipid Emulsion in people with Graft-Versus-Host Disease(GVHD), run by Fujian Medical University at 1 site in China.
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 6 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Acute Graft-versus-Host Disease (aGVHD) Within 100 Days After Allogeneic Hematopoietic Stem Cell Transplantation (time frame: Within 100 days post-transplantation). 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 18 Nov 2025.