RecruitingPhase 2NCT06254560

Rituximab for Serious Aplastic Anemia With Platelet Transfusion Refractoriness

The Study of Rituximab in the Treatment of Severe Aplastic Anemia With Platelet Transfusion Refractoriness


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

20 participants

Start Date

Feb 23, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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

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Interventions

DRUGRituximab

Rituximab is administered at a dose of 100mg per week, a total of 4 times. Cyclosporin is administered at a dose of 3-5mg/kg per day.


Locations(1)

Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

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NCT06254560


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