Zanubrutinib for treating relapsed autoimmune hemolytic anemia
Zanubrutinib in Relapsed or Refractory Warm Autoimmune Hemolytic Anemia: a Prospective Cohort Study
This study is testing if a new medication called Zanubrutinib can help adults with relapsed autoimmune hemolytic anemia feel better when other treatments haven’t worked.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | rituximab, Ibrutinib, acalabrutinib, rilzabrutinib, Zanubrutinib, cyclophosphamide |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05922839 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of Zanubrutinib, a Bruton's tyrosine kinase inhibitor, in patients with relapsed or refractory warm autoimmune hemolytic anemia (wAIHA). The study aims to provide an alternative treatment option for patients who have not responded to standard glucocorticoid therapy. Participants will be monitored for their response to the medication, with a focus on improving hemolytic symptoms and overall blood health. The trial is designed for adults aged 18 and older with a confirmed diagnosis of wAIHA or Evans syndrome.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed relapsed or refractory wAIHA who have not responded to glucocorticoid treatment.
Not a fit: Patients with uncontrolled infections, active viral infections, or other significant organ involvement in connective tissue diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients suffering from a challenging and often recurrent condition.
How similar studies have performed: While the use of BTK inhibitors like Zanubrutinib has shown success in treating various B-cell malignancies, this specific application in wAIHA is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years. 2. Confirmed diagnosis of wAIHA or Evans syndrome, primary or secondary to connective tissue disease. If it is secondary, there are no other treatment indications for systemic involvement of primary connective tissue disease. 3. No response or relapse after glucocorticoid treatment. 4. Baseline liver and kidney function (ALT, AST, Cr) is less than 2 times the normal range. 5. Consent to sign the informed consent form. Exclusion Criteria: 1. Other important organ involvement in connective tissue disease. 2. Uncontrolled infection or bleeding with standard treatment. 3. Active HIV, HCV or HBV infection uncontrolled with standard treatment. 4. Concurrent uncontrolled advanced malignant tumors or lymphoma. 5. The subject is receiving any of the following drugs and has not met the following conditions of stable drug treatment duration at a fixed dose during screening: corticosteroids for at least 4 weeks; iron, vitamin B12 or folic acid for at least 4 weeks; 6. Liver cirrhosis or portal hypertension. 7. Pregnant or lactating women. 8. Participation in other clinical trials within the last 3 months.
Where this trial is running
Beijing, Beijing
- Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Miao Chen
- Email: chenm@pumch.cn
- Phone: +86 13520112578
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.