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

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.

Inclusion criteria

• 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

Exclusion criteria

• 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)
• 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