Safety and Efficacy of LPE in Clearing DSA in Patients Who Received Allo-HSCT

Leukemia Clinical Trial

Official title:

Safety and Efficacy of LPE in Clearing DSA in Patients Who Received Allo-HSCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06177561
• Other study ID #: RuijinLjm1
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2023
• Est. completion date: November 8, 2025

Study information

• Verified date: November 2023
• Source: Ruijin Hospital
• Contact: Jiaming Li, Dr
• Phone: 0086-021-64370045
• Email: lijiaming007007[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: November 8, 2025
• Est. primary completion date: November 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia

Intervention

Procedure:
• Lymphoplasma exchange
The LPE treatment regimen is: LPE*2 times (20-30ml/kg, treatment interval of 2 days);CD20 monoclonal antibody 375mg/m2*2 times, gamma globulin 0.4g/kg/d*5d.

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The degree of decrease in DSA	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	Before LPE treatment (D0); Before stem cell transfusion; On the 10th day of stem cell transfusion;On the 30th day of stem cell transfusion