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Rituximab for Serious Aplastic Anemia With Platelet Transfusion Refractoriness

Rituximab for Serious Aplastic Anemia With Platelet Transfusion Refractoriness

Recruiting
18-70 years
All
Phase 2

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Overview

Due to long-term dependence on platelet transfusion, some severe aplastic anemia (SAA) patients suffer platelet transfusion refractoriness (PTR). Unlike immune thrombocytopenia (ITP), glucocorticoids and human immunoglobulin (IVIg) are generally ineffective for PTR. Due to the lack of effective intervention methods, patients with PTR suffer increased platelet transfusions, bleeding events and treatment costs, prolonged hospital stays, and decreased survival rate. SAA with PTR has become a challenge for physicians. The experiment aims to explore the efficacy of rituximab in the treatment of SAA with PTR, and establish a new effective, safe treatment method with relatively low treatment cost.

Description

During the treatment period, Rituximab is administered at a dose of 100mg per week, a total of 4 times.

Eligibility

Inclusion Criteria:

  • Initial diagnosed SAA with PTR
  • Age>18 years old, regardless of gender
  • Initial diagnosed SAA with PTR
  • Age>18 years old, regardless of gender

Exclusion Criteria:

  • Allergy to rituximab
  • Severe active infection
  • Hypogammaglobulinemia
  • Pregnant and lactating women
  • Heart failure (NYHA classification IV)
  • Individuals with epilepsy, dementia, and other mental disorders that require medication treatment who cannot understand or follow the research protocol
  • Chronic infections or other chronic diseases that may be risk to the experiment
  • The researchers believe that it is not suitable for participants

Study details
    Severe Aplastic Anemia
    Platelet Transfusion Refractoriness

NCT06254560

Institute of Hematology & Blood Diseases Hospital, China

20 February 2024

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