NCT06254560 Rituximab for Serious Aplastic Anemia With Platelet Transfusion Refractoriness
| NCT ID | NCT06254560 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Severe Aplastic Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-02-23 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2023-02-23 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Huang Jinbo, MD.
PRINCIPAL INVESTIGATOR
Chinese Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT06254560 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Severe Aplastic Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06254560 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06254560 currently recruiting?
Yes, NCT06254560 is actively recruiting participants. Contact the research team at huangjinbo@ihcams.ac.cn for enrollment information.
Where is the NCT06254560 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06254560 clinical trial?
NCT06254560 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Huang Jinbo, MD. at Chinese Academy of Medical Sciences. The trial plans to enroll 20 participants.