Clinical Study of rATG Individualized Administration for Prevention of GVHD and Maintenance of GVL in Haploidentical Hematopoietic Stem Cell Transplantation.
Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The purpose of this prospective, open-label, pairing design, single-center study is to evaluate the effect of individualized rATG dosing vs traditional weight-based rATG dosing regimen（10mg/kg）for patients with acute leukemia undergoing a myeloablative conditioning regimen and haploidentical hematopoietic stem cell transplantation (haplo-HSCT).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 60
Healthy Volunteers: f
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• All patients were diagnosed with acute leukemia.
• All patients should have the indication of Haploidentical hematopoietic stem cell transplant and receive the myeloablative conditioning regimen.
• All patients should sign an informed consent document indicating that they understand the purpose of and procedures required for the study and be willing to participate in the study.
Locations
Other Locations
China
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Xiaowen Tang, PhD
xwtang1020@163.com
67781525
Backup
Depei Wu, PhD
drwudepei@163.com
67781856
Time Frame
Start Date: 2022-12-20
Completion Date: 2025-05-01
Participants
Target number of participants: 90
Treatments
Experimental: Individual dose of ATG
The total individual ATG dose was calculated based on population pharmacokinetic modeling. ATG was intravenously infused every day from day -5 to day -2.
Active_comparator: ATG 10mg/kg
The total ATG dose was 10mg/kg. ATG was intravenously infused every day from day -5 to day -2.
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital of Soochow University