aGVHD Clinical Trial
Official title:
Prospective Study of Combined 4-Day ATG Regimen for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT
The purpose of this study is to determine the efficacy and safety of combined ATG #antithymocyte globulin # regimen (5mg/kg divided from day -5 to day -2) for aGVHD(acute graft-versus-host disease ) prophylaxis in matched sibling donor peripheral blood stem cell transplantation (MSD-PBSCT).
Status | Recruiting |
Enrollment | 60 |
Est. completion date | August 1, 2022 |
Est. primary completion date | August 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patients were aged from 14 to 65 years; - Patients were diagnosed of acute leukemia or MDS; - There were indications of MSD-PBSCT for these patients; - Patients without any uncontrolled infections or without severe pulmonary, renal, hepatic or cardiac diseases. Exclusion Criteria: - Patients with any uncontrolled infections or with severe pulmonary,renal, hepatic or cardiac diseases; - AML patients with t (15;17). |
Country | Name | City | State |
---|---|---|---|
China | Chinese PLA General Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese PLA General Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with severe cGVHD | Chronic graft versus host disease grading criteria (refer to NIH criteria) | 1 year | |
Secondary | Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria) | Cumulative incidence of aGVHD | 100 days | |
Secondary | OS | overall survival of enrolled patients | 1 year | |
Secondary | Number of participants relapse as assessed by NCCN (National Comprehensive Cancer Network )criteria | cumulative incidence of relapse | 1 year | |
Secondary | DFS | disease-free survival | 1 year | |
Secondary | NRM | non-relapse mortality | 1 year |
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