The Optimization of Haploidentical Hematopoietic Stem Cell Transplantation (NCT05629260) | Clinical Trial Compass
UnknownNot Applicable
The Optimization of Haploidentical Hematopoietic Stem Cell Transplantation
China300 participantsStarted 2022-12-01
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Subjects diagnosed as acute leukemia with transplant indications in ≤ CR2;
✓. Lack of available, HLA-identical, related sibling or unrelated donor;
✓. Female or male, age: 18-55 years old;
✓. ECOG performance status 0-2;
✓. Adequate organ function as defined by the following criteria:
✓. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment;
✓. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion criteria
✕. Uncontrollable active infection;
✕. Severe organic impairment: hepatic and renal impairment;
. Any of the following within 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, congestive heart failure, or cerebrovascular accident including transient ischemic attack;