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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05166967
Other study ID # S2020-484-02
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 1, 2022
Est. completion date June 1, 2024

Study information

Verified date September 2022
Source Chinese PLA General Hospital
Contact Liping Dou, Doctor
Phone 86-13681207138
Email lipingruirui@163.com
Is FDA regulated No
Health authority
Study type Interventional

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).


Description:

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Study Design


Related Conditions & MeSH terms

  • Haploidentical Hematopoietic Stem Cell Transplantation

Intervention

Drug:
Individual Antithymocyte globulin
Individual dose of ATG was Intravenous infused every day from day -5 to day -2 (total ATG dose was calculated based on pharmacokinetic index, within a range of 6 mg/kg to 13mg/kg). Prophylaxis against graft versus-host disease (GVHD) was performed with cyclosporine A (CsA), mycophenolate mofetil (MMF) and short-term methotrexate.
Antithymocyte globulin
A 10mg/kg total dose of antithymocyte globulin (ATG) was added to conditioning regimens for 4 days (from day -5 to day -2). Prophylaxis against graft versus-host disease (GVHD) was performed with cyclosporine A (CsA), mycophenolate mofetil (MMF) and short-term methotrexate.

Locations

Country Name City State
China Chinese PLA General Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative incidences of CMV reactivation The cumulative incidences of CMV reactivation in participants after transplantation, tested by CMV realtime PCR. 6 months after transplantation
Secondary Incidence of CMV disease The cumulative incidences of CMV disease in participants after transplantation, 6 months after transplantation
Secondary Cumulative incidences of aGVHD The diagnosis and grading of aGVHD are based on the modified Glucksberg grading standard. 365 days after transplantation
Secondary Cumulative incidences of cGVHD Chronic GVHD can be classified as "limited" or "extensive" according to the Seattle criteria, and also be classified as "mild" or "moderate" or "severe" according to the National Institutes of Health (NIH) criteria. 365 days after transplantation
Secondary Neutrophil engraftment Neutrophil engraftment is defined as the first of 3 consecutive days with an absolute neutrophil count > 0.5 × 10^9/L. 1 month after transplantation
Secondary Platelet engraftment Platelet engraftment is defined as the first of 7 consecutive days with an absolute platelet count > 20 × 10^9/L independent from transfusion 1 month after transplantation
Secondary Overall survival (OS) Overall survival (OS) is defined as the time from randomization to death resulting from any cause. 365 days after transplantation
Secondary Disease-free survival (DFS) Disease-free survival (DFS) is defined as the time from enrollment to relapse of primary disease or death from any cause, whichever occurred first. 365 days after transplantation
Secondary GRFS (GVHD free, relapse free survival) GRFS is defined as the time from graft infusion to the onset of grades 3 to 4 aGVHD, moderate to severe cGVHD, or relapse/disease progression/death. 365 days after transplantation
Secondary Nonrelapse mortality (NRM) Non-relapse mortality (NRM) is defined as the time from enrollment to death of any causes other than hematologic disease relapse. 365 days after transplantation
Secondary Infection rate Infection rate is defined as the proportion of participants who developed all kinds of infection 365 days after transplantation
Secondary Cumulative incidences of EBV reactivation The cumulative incidences of EBV reactivation in participants after transplantation, tested by EBV realtime PCR. 6 months after transplantation
Secondary Cumulative incidences of PTLD(posttransplant lymphoproliferative disorders) The cumulative incidences of PTLD in participants after transplantation 6 months after transplantation
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