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Status:

UNKNOWN

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

Lead Sponsor:

Ruijin Hospital

Conditions:

Leukemia

Eligibility:

All Genders

18-65 years

Phase:

NA

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...

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 al...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • 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)
  • Exclusion criteria：
  • 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.

Exclusion

    Key Trial Info

    Start Date :

    November 9 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    November 8 2025

    Estimated Enrollment :

    38 Patients enrolled

    Trial Details

    Trial ID

    NCT06177561

    Start Date

    November 9 2023

    End Date

    November 8 2025

    Last Update

    December 20 2023

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Ruijin Hospital

    Shanghai, Shanghai Municipality, China, 200025