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

NCT ID: NCT06177561

Last Updated: 2023-12-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-09
• Study Completion Date: 2025-11-08

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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LPE group

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).

Group Type: EXPERIMENTAL

Lymphoplasma exchange

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoxia Hu, Dr

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Xuefeng Wang, Dr

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Zilu Zhang, Dr

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Xiaohong Cai, Dr

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Xi Wu, Dr

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Jialu Zhao, bachelor

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiaming Li, Dr

Role: CONTACT

Phone: 0086-021-64370045

Email: lijiaming007007@126.com

Facility Contacts

Jiaming Li, Dr

Role: primary

Other Identifiers

RuijinLjm1

Identifier Type: -

Identifier Source: org_study_id