Effects of Omega-3 Fatty Acids on Acute Graft-versus-Host Disease After Allogeneic Stem Cell Transplantation.

NCT ID: NCT07162688

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-16
• Study Completion Date: 2028-06-15

Brief 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 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.

Conditions

Graft-Versus-Host Disease(GVHD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Omega-3 Lipid Emulsion Group

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.

Group Type: EXPERIMENTAL

Omega-3 Lipid Emulsion

Intervention Type: DRUG

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Omega-3 Lipid 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.

Intervention Type: DRUG

Other Intervention Names

ω-3 Lipid Emulsion; Omega-3 PUFA; Omega-3 Fatty Acid Emulsion

Eligibility Criteria

Inclusion Criteria

1. Patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT)

2. Age 18 to 65 years (inclusive)

3. Male or female

4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3

5. Expected survival of at least 100 days

6. Willingness to participate and provide written informed consent

Exclusion Criteria

1. History of solid organ transplantation

2. Serum triglycerides ≥ 7.9 mmol/L

3. Uncontrolled diabetes

4. Severe dyslipidemia (e.g., LDL-C ≥ 4.9 mmol/L)

5. Contraindications to parenteral nutrition (e.g., severe electrolyte imbalance, acidosis)

6. Severe hepatic impairment (AST/ALT > 3× ULN)

7. Creatinine clearance < 15 mL/min

8. Known allergy to Omega-3, fish, or egg protein

9. Significant psychiatric illness or substance abuse interfering with study compliance

10. Participation in another clinical trial or receipt of other experimental treatments during the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ting YANG

The First Affiliated Hospital of Fujian Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ting Yang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Fujian Medical University

Locations

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Countries

China

Other Identifiers

In-hospital project fund

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Omega3-aGVHD-01

Identifier Type: -

Identifier Source: org_study_id