Clinical trial NCT06177561: Safety and Efficacy of LPE in Clearing DSA in Patients Who Received Allo-HSCT
Official title: Safety and Efficacy of LPE in Clearing DSA in Patients Who Received Allo-HSCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Leukemia
Keywords: lymphoplasma exchange,LPE
donor specific antibody,DSA
allogeneic hematopoietic stem cell transplantation，allo-HSCT
graft failure,GF
graft-versus-host disease，GVFHD
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: We recruited 38 patients according to the inclusion 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).)

Sample the peripheral blood of the patient at four timepoints（Before LPE treatment (D0); Before stem cell transfusion; On the 10th day of stem cell transfusion;On the 30th day of stem cell transfusion).Using multiplex bead analysis on the Luminex platform (Luminex Corporation, Austin, TX, USA), including the LAB screening PRA and LAB screening hybrid method, all patients' ethylenediamine tetraacetic acid (EDTA)-treated serum was tested for anti-HLA class I and class II antibodies.According to the manufacturer's instructions, the semi-quantitative measurement of DSA levels was performed by LAB screening single antigen beads assay (One Lambda; ThermoFisher), and the results were expressed as MFI.The cumulative DSA MFI was calculated by summing the MFI of all detected DSA under HLA antigen resolution.

Evaluate the effectiveness of LPE by comparing it with the historical control group that has undergone TPE treatment in the past

Eligibility 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.

Primary outcomes:
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
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Xiaoxia Hu, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Xuefeng Wang, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Zilu Zhang, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Xiaohong Cai, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Xi Wu, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Jialu Zhao, bachelor
role: PRINCIPAL_INVESTIGATOR
References: