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Trial Title:
Clinical Study of rATG Individualized Administration in Haploidentical Hematopoietic Stem Cell Transplantation
NCT ID:
NCT05634915
Condition:
Hematopoietic Stem Cell Transplantation
Acute Leukemia
Conditions: Official terms:
Leukemia
Conditions: Keywords:
Antithymocyte Globulin
Population pharmacokinetic model
Haploidentical Hematopoietic Stem Cell Transplantation
Acute Leukemia
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Individual ATG
Description:
Individual dose of ATG: Individual dose of ATG was Intravenous infused every day from day
-5 to day -2 (total ATG dose was calculated based on population pharmacokinetic
modeling). Prophylaxis against graft-versus-host disease (GVHD) was performed with
cyclosporine A, mycophenolate mofetil, and low-dose methotrexate.
Arm group label:
Individual dose of ATG
Intervention type:
Drug
Intervention name:
ATG
Description:
ATG 10mg/kg: The total ATG dose was 10mg/kg. ATG was intravenously infused every day from
day -5 to day -2. Prophylaxis against graft-versus-host disease (GVHD) was performed with
cyclosporine A, mycophenolate mofetil, and low-dose methotrexate.
Arm group label:
ATG 10mg/kg
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).
Detailed description:
Allogeneic hematopoietic stem-cell transplantation (HSCT) is a potentially curative
treatment option for acute leukemia. Haploidentical hematopoietic stem cell
transplantation (haplo-HSCT) has become the main choice for acute leukemia in China.
Major difficulties of the procedure include graft-versus-host disease (GVHD), graft
failure, and relapse. As an important role of haplo-HSCT, Rabbit anti-thymocyte globulin
(rATG), a polyclonal rabbit-derived antibody that depletes lymphocytes, including T
cells, was introduced to prevent GVHD and transplant rejection.
The recommended dose of rATG in haplo-HSCT is 10 mg/kg. However, while the traditional
weight-based rATG dosing regimen (10mg/kg) reduces the incidence of GVHD, it increases
the risk of delayed immune reconstitution, viral reactivation, and relapse in patients.
Our previous retrospective study showed that active ATG exposure (area under the curve,
AUC)) post-transplantation is associated with immune reconstitution, GVHD, relapse,
survival, and viral reactivation in HSCT of acute leukemia patients. Identifying the
optimal dose of ATG to achieve the optimal exposure range of active ATG is a pressing
clinical issue.
The pharmacokinetics of ATG varies significantly in both pediatric and adult populations,
especially the active ATG levels, and clarifying the relationship between the
pharmacokinetics of ATG and the prognosis of patient outcomes can help in precise
treatment. By constructing a population pharmacokinetic model of ATG, we can provide an
individualized optimal dose of ATG based on factors prior to transplantation. ATG
individualized administration may improve the survival and quality of life of patients
undergoing haplo-HSCT. A prospective pairing design trial is required to evaluate the
effect of individualized rATG dosing vs traditional weight-based rATG dosing regimen
(10mg/kg) for patients with acute leukemia undergoing haplo-HSCT.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. All patients were diagnosed with acute leukemia.
2. All patients should have the indication of Haploidentical hematopoietic stem cell
transplant and receive the myeloablative conditioning regimen.
3. 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.
Exclusion Criteria:
Patients with any conditions not suitable for the trial (investigators' decision).
Gender:
All
Minimum age:
16 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaowen Tang, PhD
Phone:
67781525
Email:
xwtang1020@163.com
Start date:
December 20, 2022
Completion date:
May 1, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05634915
