Rituximab for Serious Aplastic Anemia With Platelet Transfusion Refractoriness

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT06254560
Phase
PHASE2
Status
Recruiting
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Conditions

  • Platelet Transfusion Refractoriness
  • Severe Aplastic Anemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 23, 2023
Status verified
Feb 2023
Primary completion
Dec 30, 2026
Completion
Dec 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: rituximab group
    Rituximab combined with cyclosporine

Primary Outcome Measure

The response and complete remission rate with Rituximab protocol. [ Time Frame: 6 months ]

Central Contacts

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