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Recruiting Phase 2 NCT06378060

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

Trial Parameters

Condition Severe Aplastic Anemia
Sponsor Hematology department of the 920th hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 30
Sex ALL
Min Age 3 Years
Max Age 65 Years
Start Date 2024-03-01
Completion 2026-04-01
Interventions
Modified transplantation system

Brief Summary

The aim of this study was to evaluate the safety and efficacy of a modified allogeneic hematopoietic stem cell transplantation regimen for aplastic anemia.

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

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