Clinical Study on Modified Allogeneic Hematopoietic Stem Cell Transplantation Regimen for Severe Aplastic Anemia

Launched by HEMATOLOGY DEPARTMENT OF THE 920TH HOSPITAL · Apr 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treating severe aplastic anemia, a serious condition where the body doesn't produce enough blood cells. The researchers want to see if a modified stem cell transplant method is safe and effective for patients. The trial is currently looking for participants aged 3 to 65 who have certain blood disorders and need this type of transplant. To be eligible, patients should be in relatively good health and not have any severe infections or major organ issues.

If you or someone you know is considering joining this trial, participants will receive the modified stem cell transplant and will be monitored closely for any side effects or improvements in their condition. It's important that those interested can voluntarily participate and give informed consent, meaning they understand the study and agree to take part. This trial could potentially offer a new treatment option for those struggling with severe aplastic anemia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with benign or malignant hematological diseases such as leukemia, lymphoma, thalassemia, aplastic anemia, etc. diagnosed by NCCN guidelines, and requiring allogeneic hematopoietic stem cell transplantation as determined by the researchers;
• • 2. Age 3-65 years old;
• • 3. Weight 10Kg-100Kg;
• • 4. Eastern Cooperative Oncology Group (ECOG) score ≤3;
• • 5. No major organ injury (ECG ejection fraction \>45%; bilirubin \< 2 times the upper limit of normal value; AST and ALT \< 3 times the upper limit of normal value; serum creatinine \< 2 times the upper limit of normal value);
• • 6. No severe infection;
• • 7. Subjects voluntarily participated in this clinical trial and signed the informed consent.
• Exclusion Criteria:
• • 1. patients with nonhematologic diseases who are not eligible for transplantation or who do not wish to receive transplantation;
• • 2. patients with an expected survival of less than 1 month;
• • 3. patients with previous autologous or allogeneic hematopoietic stem cell transplantation;
• • 4. pregnant patients;
• • 5. patients with severe mental or neurological disorders that would affect the ability to provide informed consent and/or to report or observe adverse events;
• • 6. other conditions that the investigator determines to be inappropriate for enrollment.