Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine the response and toxicity rate of two different dosages (Individualized dosage VS. fixed dosage) of ATG as a prophylaxis for acute GVHD in haploidentical peripheral blood stem cell transplantation (haplo-PBSCT).


Clinical Trial Description

Acute graft-versus-host disease (aGvHD) is an important complication of haplo-HSCT. The Seattle group initially introduced the use of ATG as a treatment for acute graft-versus-host disease (aGVHD) in allogeneic hematopoietic stem cell transplantation (haplo-PBSCT) recipients. Presently, in both myeloablative and reduced-intensity conditioning (RIC) haplo-PBSCT, ATG is part of postengraftment immunosuppressive regimens. The regimens for prophylaxis of GVHD based on 10mg/kg rabbit anti-human thymocyte immunoglobin (ATG, Thymoglobulin®, Genzyme Polyclonals S.A.S) effectively reduced the occurrence of grade II-IV aGvHD. However, the incidence of cytomegalovirus (CMV) and EB virus (EBV) reactivation were higher due to a slower immune reconstitution. The 100-day cumulative incidence of CMV and EBV viremia were both over 70% in our unmanipulated haplo-PBSCT program. The optimal dose of ATG balancing the efficacy of GVHD prophylaxis and the risk of virus reactivation in haplo-PBSCT remains unknown. Reports on the pharmacokinetics of Thymoglobulin in allo-HSCT revealed a high variability. Recent pharmacokinetic studies have shown that the half-life of total ATG after transplant is longer than the active ATG (which is available to bind to human lymphocytes and causes the desired immunological effects). And active ATG appears more associated with pharmacodynamics effects. The investigators found that virus reactivation and acute GVHD were highly affected by ATG exposure (area under the curve, AUC) in previous cohort study. The investigators have found an optimal range of active ATG exposure balancing the efficacy of GVHD prophylaxis and the risk of virus reactivation. The incidence of CMV reactivation and III-IV aGVHD reduced to 60%, 6% respectively. The results suggested that Individualized dosing of ATG has a potential advantage in balancing the efficacy of GVHD prophylaxis and the risk of virus reactivation in haplo-PBSCT. This may improve the survival and quality of life of patients undergoing haplo-PBSCT. A prospective randomized trial is required to compare the efficacy of Individualized dosage of ATG as a prophylaxis for acute GVHD in haplo-PBSCT. ;


Study Design


Related Conditions & MeSH terms

  • Haploidentical Hematopoietic Stem Cell Transplantation

NCT number NCT04778618
Study type Interventional
Source Chinese PLA General Hospital
Contact
Status Active, not recruiting
Phase Phase 2
Start date December 1, 2020
Completion date January 14, 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05622032 - Blood Virome After Haploidentical Hematopoietic Stem Cell Transplantation, a Pilot Study
Recruiting NCT06041893 - Haploidentical Hematopoietic Stem Cell Transplantation With Early ATG and Low Dose Post-transplant Cyclophosphamide
Recruiting NCT06423131 - Prospective Clinical Trial for Children With TCRαβ Depleted vs Traditional Haplo Identicle HSCT N/A
Recruiting NCT02014506 - Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation in Children and Adolescents Phase 1/Phase 2
Recruiting NCT05166967 - Individualized Dose Study of ATG in Haploidentical Hematopoietic Stem Cell Transplantation Phase 4
Completed NCT03236220 - Effect of NAC on the Hematopoietic Reconstitution After Haploidentical Hematopoietic Stem Cell Transplantation Phase 2
Recruiting NCT06381817 - Haplo-cord HCT vs. Haplo-HCT for T-ALL Patients Phase 3