Rituximab for Serious Aplastic Anemia With Platelet Transfusion Refractoriness

Last updated: February 3, 2024
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Overall Status: Active - Recruiting

Phase

2

Condition

Aplastic Anemia

Anemia

Treatment

Rituximab

Clinical Study ID

NCT06254560
2023NCRCA0113
  • Ages 18-70
  • All Genders

Study 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 Criteria

Inclusion

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

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 requiremedication 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 Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Rituximab
Phase: 2
Study Start date:
February 23, 2023
Estimated Completion Date:
December 30, 2027

Study Description

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

Connect with a study center

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

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

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