Using Rituximab to treat severe aplastic anemia with platelet transfusion issues
The Study of Rituximab in the Treatment of Severe Aplastic Anemia With Platelet Transfusion Refractoriness
This study is testing if rituximab can help people with severe aplastic anemia who have trouble getting enough platelets from transfusions.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06254560 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of rituximab in patients suffering from severe aplastic anemia (SAA) who experience platelet transfusion refractoriness (PTR). The study aims to provide a new treatment option for these patients, who currently face challenges with existing therapies. Participants will receive rituximab at a dosage of 100mg weekly for four weeks. The goal is to establish a safe and effective treatment method that is also cost-efficient.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have been newly diagnosed with severe aplastic anemia and are experiencing platelet transfusion refractoriness.
Not a fit: Patients with allergies to rituximab, severe active infections, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the need for platelet transfusions and improve the quality of life for patients with severe aplastic anemia and PTR.
How similar studies have performed: While the use of rituximab in other conditions has shown promise, this specific application for severe aplastic anemia with PTR is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tianjin, Tianjin Municipality
- Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Principal investigator: Huang Jinbo, MD. — Chinese Academy of Medical Sciences
- Study coordinator: Huang Jinbo, MD.
- Email: huangjinbo@ihcams.ac.cn
- Phone: +86 22 23909023
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.