NCT06254560

Rituximab for Serious Aplastic Anemia With Platelet Transfusion Refractoriness

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Severe Aplastic Anemia
• Platelet Transfusion Refractoriness

Interventions

Type	Name	Description
DRUG	Rituximab	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.

Timeline

• Start date: 2023-02-23
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2024-02-12
• Last updated: 2024-02-12

Locations

1 site across 1 country: China