Clinical Trials in China / NCT07862127
Recruiting
Phase 3
Population PK-guided ATG Dosing for Haploidentical Hematopoietic Stem Cell Transplantation
NCT07862127 · tracked via the Priya Life Science China tracker
Condition(s) studied
Hematopoietic Stem Cell Transplantation
Investigational drug(s) / intervention(s)
Anti-Thymocyte Globulin (ATG): ATG (Thymoglobulin) IV, total dose 6-10 mg/kg (PK-guided, targeting AUC 100-148.5 IU·day/mL) for experimental arm; fixed 10 mg/kg for control arm, both given over Days -5 to -3 pre-transplant, combined with standard GVHD prophylaxis.
Study 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
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.
Primary outcome measure(s)
- 1-year GVHD-free and relapse-free survival rate(1-year-GRFS) — 1 years after treatment
GRFS is defined as the time from randomization to the first occurrence of grade III-IV acute GVHD, chronic GVHD requiring systemic immunosuppressive therapy, or death due to disease relapse, whichever occurs first. The cumulative incidence of GRFS will be estimated using the Fine-Gray competing risk model.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07862127 on ClinicalTrials.gov ↗ ← All trials in China