Using lymphoplasma exchange to clear donor-specific antibodies in leukemia patients undergoing stem cell transplantation
Safety and Efficacy of LPE in Clearing DSA in Patients Who Received Allo-HSCT
This study is testing if a treatment called lymphoplasma exchange can help leukemia patients getting a stem cell transplant by removing harmful antibodies from their blood.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06177561 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of lymphoplasma exchange (LPE) in clearing donor-specific antibodies (DSA) in patients scheduled for allogeneic hematopoietic stem cell transplantation (allo-HSCT). A total of 38 patients will be recruited based on specific inclusion criteria, including being DSA positive and having normal organ function. Blood samples will be collected at four time points to measure DSA levels using advanced multiplex bead analysis. The study seeks to determine the clinical efficacy of LPE in improving outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who are DSA positive and scheduled for allo-HSCT with normal organ function.
Not a fit: Patients with severe allergies to blood products or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the success rates of stem cell transplants by reducing the risk of graft failure and graft-versus-host disease.
How similar studies have performed: While the use of lymphoplasma exchange is a novel approach in this context, similar studies have shown promise in managing donor-specific antibodies in transplant patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Serum DSA positive: MFI ≥ 2000；Between the ages of 18 and 65, male and female are not limited；Planned to undergo allo-HSCT , with an estimated survival time of\>3 months and an ECOG physical fitness score of 0-2；Normal renal function (BUN, Cr ≤ 1.5 times the upper limit of normal value, Ccr\>80ml/min) 2. Normal liver function (defined as ALT and AST ≤ 1.5 times the upper limit of normal 3. TBiL ≤ 1.5 times the upper limit of normal) 4. ECG did not indicate any AMI, arrhythmia, or IAVB 5. No CI (defined as LVEF ≥ 50%, normal MYO and BNP) 6. Non active RHD 7. Chest X-ray or physical examination did not indicate cardiac dilatation 8. Normal lung function (defined as FEV1, FVC, DLCO ≥ 60% predicted value) Exclusion criteria： 1. Patients with severe allergies to blood products 2. The following comorbidities exist: active infection patients, active rheumatism patients 3. Patients with secondary immunoglobulin deficiency 4. Serious damage to important organ functions, such as respiratory failure, heart failure, decompensated liver dysfunction, renal dysfunction, etc 5. Unable to obtain informed consent.
Where this trial is running
Shanghai, Shanghai
- Ruijin Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Xiaoxia Hu, Dr — Ruijin Hospital
- Study coordinator: Jiaming Li, Dr
- Email: lijiaming007007@126.com
- Phone: 0086-021-64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.