The Combination of ATRA and Eltrombopag as the Treatment of Steroid-resistant/Relapse ITP Based on MSC-C5b-9

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Jun 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for a condition called immune thrombocytopenia (ITP), specifically in patients who have not responded well to steroid treatments or have had their symptoms return. The trial is comparing two treatment options: one group will receive a combination of two medications, ATRA and eltrombopag, while another group will receive only eltrombopag. The goal is to see which option is more effective and safer for improving platelet counts, as low platelet counts can lead to bleeding and bruising.

To be eligible, participants should be adults over 18 years old with very low platelet counts (less than 30 per microliter of blood) and have already tried hormone treatments without success. They must also meet certain health criteria, such as having normal blood cell levels and a healthy spleen. During the trial, participants can expect to visit the study site for assessments and treatment, and they will be monitored closely for any side effects. This trial is currently recruiting participants, so if you or someone you know fits the criteria, it might be worth considering.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Isolated thrombocytopenia (platelet count \<30 × 109/L); 2. age \> 18 years; 3. normal white blood cells and red blood cells on bone marrow examination; 4. increased number of megakaryocytes (bone marrow examination was performed in all patients except for myelofibrosis or other conditions that can cause thrombocytopenia disease); 5. the spleen was normal in size; 6. Eastern Cooperative Oncology Group status score (ECOG score) ≤ 2; 7. ineffective or relapsed after at least 1 course of full-dose full-course hormone therapy; 8. Failure of prior ITP therapy (eg, hormones, splenectomy, and cyclosporine) and at least 4 weeks from enrollment.
• Exclusion Criteria:
• • 1. Secondary ITP such as drug-related thrombocytopenia; 2. thrombocytopenia due to viral infection (HIV, hepatitis B virus, or hepatitis C virus); 3. severe cardiac, renal, hepatic, or respiratory insufficiency; 4. severe immunodeficiency; 5. pregnancy or lactation; 6. myelodysplasia or Myelofibrosis; 7. history of malignancy; 8. ongoing immunosuppressive therapy for other diseases; 9. patients previously treated with eltrombopag were excluded from this study.