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ATG Individualized Dosing Model in URD-PBSCT.

RecruitingPhase 2Ages 14 Years - 65 YearsAllChinese PLA General Hospital
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In plain words

What the trial is, and whether it could suit you

Anti-thymocyte globulin (ATG) is widely used in allogeneic hematopoietic stem cell transplantation to prevent severe graft-versus-host disease (GVHD) and graft failure. However, overexposure to ATG may increase cytomegalovirus (CMV), Epstein-Barr virus (EBV) reactivation, non-relapse mortality, and disease recurrence. A targeted dosing strategy was established based on ATG concentration monitoring and conducted a phase 2 trial to evaluate the safety and efficacy of the dosing strategy in adult unmanipulated haplo-PBSCT, a encouraging result was attained. In this trial, The ATG-targeted dosing strategy was extended to adult unrelated donor allogeneic hematopoietic stem cell transplantation, ATG was administered for 4 days (-5 days to -2 days) during conditioning. The ATG doses on-3 days and- 2days were adjusted by our dosing strategy to achieve the optimal ATG exposure. The primary endpoi

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Patients with malignant hematological tumors who have indications for allogeneic hematopoietic stem cell transplantation. 2. HLA-matched unrelated donor 3. Patient age โ‰ฅ14 years old and โ‰ค65 years old 4. ALT and AST โ‰ค 2.5 times the upper limit of normal values, bilirubin โ‰ค 2 times the upper limit of normal values 5. Creatinine โ‰ค high limit of normal value 6. No uncontrollable infection or serious mental illness 7. Physical strength score is 0-2 (ECOG) 8. Sign the informed consent form Exclusion Criteria: 1. Unrelated donor who is not HLA matched 2. No indication for allogeneic hematopoietic stem cell transplantation 3. Patient age \<14 years old or \>65 years old 4. The donor or recipient are pregnant 5. Suffering from mental illness or other conditions and being unable to proceed as planned
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What it tests

  • individualized ATG dosing strategy
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Where

1 site
Department of Hematology, First Medical Center of Chinese PLA General Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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