Rituximab for Serious Aplastic Anemia With Platelet Transfusion Refractoriness

Institute of Hematology & Blood Diseases Hospital, China

Status and phase

Enrolling

Phase 2

Conditions

Platelet Transfusion Refractoriness

Severe Aplastic Anemia

Treatments

Drug: Rituximab

Study type

Interventional

Funder types

Other

Identifiers

NCT06254560

2023NCRCA0113

Details and patient eligibility

About

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.

Full description

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

Enrollment

20 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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