Effects and Mechanism of Omega-3 Polyunsaturated Fatty Acids on Acute Graft-versus-host Disease (aGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence and Severity of Acute Graft-versus-Host Disease (aGVHD) Within 100 Days After Allogeneic Hematopoietic Stem Cell Transplantation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
This is an open-label trial. No participants, care providers, investigators, or outcome assessors are masked to group assignments.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Omega-3 Lipid Emulsion (Drug)
结局指标
主要结局
Incidence and Severity of Acute Graft-versus-Host Disease (aGVHD) Within 100 Days After Allogeneic Hematopoietic Stem Cell Transplantation
时间窗: 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.
次要结局
- Progression-Free Survival (PFS) at Day 100 Post-Transplantation(100 days post-transplantation)
研究者
Ting YANG
The First Affiliated Hospital of Fujian Medical University
Fujian Medical University