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

NCT06177561 | Unknown

• 1 other identifier: RuijinLjm1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

LPE group

EXPERIMENTAL

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).

Procedure: Lymphoplasma exchange

Interventions

Lymphoplasma exchange 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.

LPE group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Normal liver function (defined as ALT and AST ≤ 1.5 times the upper limit of normal
• TBiL ≤ 1.5 times the upper limit of normal)
• ECG did not indicate any AMI, arrhythmia, or IAVB
• No CI (defined as LVEF ≥ 50%, normal MYO and BNP)
• Non active RHD
• Chest X-ray or physical examination did not indicate cardiac dilatation
• Normal lung function (defined as FEV1, FVC, DLCO ≥ 60% predicted value)

You may not qualify if:

• Patients with severe allergies to blood products
• The following comorbidities exist: active infection patients, active rheumatism patients
• Patients with secondary immunoglobulin deficiency
• Serious damage to important organ functions, such as respiratory failure, heart failure, decompensated liver dysfunction, renal dysfunction, etc
• Unable to obtain informed consent.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Xiaoxia Hu, Dr

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Xuefeng Wang, Dr

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Zilu Zhang, Dr

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Xiaohong Cai, Dr

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Xi Wu, Dr

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Jialu Zhao, bachelor

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaming Li, Dr

CONTACT

0086-021-64370045; lijiaming007007@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: November 9, 2023
• Primary Completion: November 8, 2024
• Study Completion: November 8, 2025
• Last Updated: December 20, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)