Rituximab for Serious Aplastic Anemia With Platelet Transfusion Refractoriness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-23

Study Completion Date

2027-12-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Severe Aplastic Anemia Platelet Transfusion Refractoriness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rituximab group

Rituximab combined with cyclosporine

Group Type EXPERIMENTAL

Rituximab

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Mabthera

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No