Clinical trial · Interventional
Safety and Efficacy of LPE in Clearing DSA in Patients Who Received Allo-HSCT
NCT06177561CI-TRIAL-00072406unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to prospectively explore the effectiveness and safety of LPE in clearing DSA, and to investigate the clinical efficacy of a combination therapy with LPE in patients undergoing genetic hematopoietic stem cell transplantation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lymphoplasma exchange | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LPE group
- description
- 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).
- interventionNames
- Procedure: Lymphoplasma exchange
Primary outcomes (1)
- measure
- The degree of decrease in DSA
- timeFrame
- Before LPE treatment (D0); Before stem cell transfusion; On the 10th day of stem cell transfusion；On the 30th day of stem cell transfusion
- description
- A semiquantitative measurement of the DSA level was performed by LAB screen single antigen bead assays (One Lambda; Thermo Fisher) and the results were expressed as MFI
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.