The goal of this observational study is to compare the incidence of relapse in G-CSF/ATG based and PT-Cy based haploidentical transplantation\] in \[patients aged 18 to 55 years with a diagnosis of hematological malignancies who unmanipulated haplo-HSCT with myeloablative conditioning\]. The main question it aims to answer are: Primary objective: To compare the incidence of relapse in G-CSF/ATG based and PT-Cy based haploidentical transplantation and illustrate the possible immune mechanism. Secondary objectives: To compare CMV infection, GVHD and survival outcomes, and to observe the dynamic immune reconstitution of G-CSF/ATG based or PT-Cy based model. Exploratory objectives: To compare the long-term quality of life among recipients who receive G-CSF/ATG based or PT-Cy based protocol.
Study Type
OBSERVATIONAL
Enrollment
300
Patients with intermediate-high risk hematologic malignancy who are indicated for allogeneic hematopoietic stem cell transplantation (allo-HSCT) and absence of HLA matched donors will be treated with haplo-HSCT, with G-CSF/ATG based protocol.
Patients with intermediate-high risk hematologic malignancy who are indicated for allogeneic hematopoietic stem cell transplantation (allo-HSCT) and absence of HLA matched donors will be treated with haplo-HSCT with PT-Cy based protocol.
People's Hospital of Peking University
Beijing, Beijing Municipality, China
RECRUITINGPercent of participants with disease relapse
The cumulative incidence of relapse of the primary disease.
Time frame: 1 year
Incidence of CMV disease
The cumulative incidences of CMV disease in participants after transplantation
Time frame: 6 months
Cumulative incidences of aGVHD
The diagnosis and grading of aGVHD are based on the modified Glucksberg grading standard.
Time frame: 100 days
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.
Time frame: 1 year
Percent of participants with overall survival
Overall survival (OS) is defined as the time from randomization to death resulting from any cause.
Time frame: 1 year
Dynamic immune reconstitution
The main immune cell subsets include: T cell, B cell, NK cell, and Monocytes
Time frame: 1 year
Neutrophil engraftment
Neutrophil engraftment is defined as the first of 3 consecutive days with an absolute neutrophil count \> 0.5 × 10\^9/L.
Time frame: 1 month
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
Time frame: 1 month
Transplantation-related mortality
Death due to causes unrelated to the underlying disease
Time frame: 1 year
Xiao-Jun Huang, M.D
CONTACT
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