Rituximab for Serious Aplastic Anemia With Platelet Transfusion Refractoriness (NCT06254560) | Clinical Trial Compass
RecruitingPhase 2
Rituximab for Serious Aplastic Anemia With Platelet Transfusion Refractoriness
China20 participantsStarted 2023-02-23
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The response and complete remission rate with Rituximab protocol.
Timeframe: 6 months
Trial details
NCT IDNCT06254560
SponsorInstitute of Hematology & Blood Diseases Hospital, China