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NCT07862127
Population PK-guided ATG Dosing for Haploidentical Hematopoietic Stem Cell Transplantation
Conditions: Hematopoietic Stem Cell Transplantation
Sex: All
Ages: 14 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 324
Sponsor: Daihong Liu
Location: Chinese PLA General Hospital Beijing Beijing Municipality
Summary
To evaluate the safety and efficacy of a population pharmacokinetics (PK)-guided targeted ATG dosing strategy in haploidentical stem cell transplantation and to observe the GVHD-free, relapse-free survival (GRFS) in the cohort receiving this strategy.
Eligibility Criteria
Inclusion Criteria:
* Patients with indications for allogeneic hematopoietic stem cell transplantation, with malignant hematologic diseases in CR1 or CR2 before transplantation.
* Have an HLA-matched sibling, unrelated, or haploidentical donor.
* Age ≥ 14 years and ≤ 75 years.
* Liver function: ALT and AST ≤ 2.5 × upper limit of normal, bilirubin ≤ 2 × upper limit of normal.
* Renal function: creatinine ≤ upper limit of normal.
* No uncontrolled infection or severe mental or psychological disorders.
* ECOG performance status score of 0-2.
* Signed informed consent.
Exclusion Criteria:
* No HLA-matched donor.
* Malignant hematologic disease in CR3 or higher disease stage, or refractory/relapsed status.
* Patient age \< 14 years or \> 75 years.
* Pregnancy of either the donor or the recipient.
* Presence of mental illness or other conditions that preclude compliance with the protocol.
Source: ClinicalTrials.gov (NCT07862127). StuddyBuddy aggregates publicly available trial information.