Using CD20 monoclonal antibody to prevent GVHD in patients with aplastic anemia undergoing transplant
Official title: A Prospective, Randomized, Multi-center Study to Assess the Efficacy and Safety of GVHD Prophylaxis by Addition of CD20 Monoclonal Antibody to the Conditioning Regimen in Severe Aplastic Anemia Patients With Treatment of Allogeneic HSCT
Run by The First Affiliated Hospital of Soochow University · NCT05510505 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if adding a CD20 monoclonal antibody to the treatment plan can help prevent graft-versus-host disease in patients with severe aplastic anemia who are getting a stem cell transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 50 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | The First Affiliated Hospital of Soochow University Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT05510505 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients under 50 years old with severe aplastic anemia who are eligible for allo-HSCT and have a performance status of at least 70.
✕Probably not a fit
Patients with severe comorbidities or those over 50 years old may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the addition of a CD20 monoclonal antibody to the conditioning regimen for patients with severe aplastic anemia (SAA) undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). It aims to compare the incidence and severity of acute and chronic graft-versus-host disease (GVHD), engraftment rates, and infection rates between two groups: one receiving the antibody and one not. The study is randomized and controlled, enrolling 200 patients over a period of 63 months, with follow-up extending for two years post-transplant. Additionally, it includes pharmacogenomic assessments and monitoring of B cell levels and immunoglobulin levels in participants.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of GVHD and improve transplant outcomes for patients with aplastic anemia.
How similar studies have gone: While the use of CD20 monoclonal antibodies in this context is relatively novel, previous studies have shown promise in reducing GVHD in other transplant settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects eligible for inclusion in this study must meet all of the following criteria: 1. SAA characterized Bone marrow cellularity\< 25%, or 25-50% with \<30% residual hematopoietic cells and pancytopenia, with at least two of the following parameters in peripheral blood Absolute neutrophil count \< 0.5\*10E9/L Platelet count \< 20\*10E9/L Absolute reticulocyte count \< 20\*10E9/L 2. ALL patients will undergo allo-HSCT. 3. Subjects aged \<50 years old with KPS performance status ≥70 at the same time. 4. Aspartate aminotransferase (AST) , alanine aminotransferase (ALT) and alkaline phosphatase≤2 times the upper limit of normal (ULN). Blood urea nitrogen and Creatinine ≤1.25 times ULN. 5. Cardiac function of subjects must meet all of the following requirements: ECG examination do not reveal any acute myocardial infarction, arrhythmia, or first-degree or higher atrioventricular block. No signs of heart failure. No carrying of active rheumatoid heart disease. Chest radiograph or physical examination do not indicate an enlarged heart. 6. ALL subjects show none contraindication for allogeneic hematopoietic stem cell transplantation. 7. Patients enrolled in the rituximab group have no contraindications for the use of rituximab. 8. Patients and their clients are willing to perform hematopoietic stem cell transplantation. 9. Potential donor is accessible. 10. Patients have no anti-HLA antibodies. Exclusion Criteria: 1. Subject who is unable comprehend or is unwilling to sign an informed consent form or consent form due to severe physical or mental illness resulting in a survival of less than 2 years. 2. Presence of clinically active uncontrolled significant chronic infections (including bacterial, fungal or viral infection), such as dental caries, otitis media, sinusitis, etc., need to be carried out after effective control. 3. Past medical history of severe pulmonary dysfunction. 4. Past medical history of diabetes with a propensity for ketoacidosis. 5. Presence of severe coagulopathy, thrombophlebitis or pulmonary embolism. 6. Presence of decompensated liver insufficiency or active hepatitis. 7. Presence of history of severe autoimmune disease. 8. Past medical history of thyroid dysfunction with currently abnormal thyroid function. 9. Any concomitant malignancies that have not been disease-free for 5 years. 10. Past medical history of hypersensitivity to biological products (including antibiotics). 11. Pregnant or nursing woman. 12. Inherited bone marrow failure.
Where it's running
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China Recruiting
Study contacts
- Principal investigator: depei wu — The First Affiliated Hospital of Soochow University
- Study coordinator: depei wu
- Email: wudepei@suda.edu.cn
- Phone: 67781856
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Isatuximab in adults with refractory severe aplastic anemia
This study tests whether the drug isatuximab can help adults with refractory severe aplastic anemia who have very low blood counts.
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Brain network changes in adults with anemia measured by fNIRS
This project will use functional near-infrared spectroscopy (fNIRS) to see if brain network connections are altered in adults aged 18–65 who have anemia.
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Daratumumab for refractory aplastic anemia in adults
This trial tests whether daratumumab can be safely given and help people with refractory aplastic anemia see a benefit.
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High-altitude stem cell and bone marrow transplant registry on the Qinghai-Tibet Plateau
This project will collect clinical data and blood/bone marrow samples from people having hematopoietic stem cell transplants on the Qinghai‑Tibet Plateau to see how high altitude affects transplant outcomes and recovery.
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Predicting pregnancy risks for women with aplastic anemia
This project will try to create a model to predict which pregnant women with aplastic anemia are most likely to have maternal or newborn complications.
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Impact of Aplastic Anemia on Reproductive and Mental Health
This study looks at how aplastic anemia and its treatments affect the reproductive and mental health of young adults aged 18-40.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.