This study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. This project plans to use highly mismatched unrelated HLA mismatched donors. Ultimately, an unrelated human leukocyte antigen (HLA) mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of this group of patients and truly enter the era of "everyone has a donor" for allo HSCT.
This study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. This project plans to use highly mismatched unrelated HLA mismatched donors. Ultimately, an unrelated human leukocyte antigen (HLA) mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of this group of patients and truly enter the era of "everyone has a donor" for allo HSCT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Myeloablative conditioning: Busulfan (Bu，3.2 mg/kg/d IV -8d \~-6d); Reduced intensity conditioning: Busulfan (Bu，3.2 mg/kg/d IV -7d\~-5d);
Myeloablative conditioning: Cyclophosphamide (Cy，1.8g/m2, -5d, -4d) Cyclophosphamide is not used for reduced intensity conditioning
Myeloablative conditioning: Fludarabine (Flu，30 mg/m2/d IV -6d \~ -2d); Reduced intensity conditioning: Fludarabine (Flu，30mg/m2 /d IV -10d\~-5d);
For both myeloablative and reduced intensity conditioning: Semustine (MeCCNU: 250 mg/m2 orally-3d)
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
RECRUITINGOverall survival
Overall survival (OS) after allogeneic hematopoietic cell transplantation is defined as the proportion of patients who are alive at a specified time point following the transplantation, regardless of disease status or cause of death.
Time frame: 1-year
Neutrophil engraftment rate
The 28-day neutrophil engraftment rate is assessed, with neutrophil engraftment defined as achievement of an absolute neutrophil count (ANC) of ≥ 0.5 × 10⁹/L for three consecutive days.
Time frame: 28-days
Platelet engraftment rate
The 28-day platelet engraftment rate is assessed, with platelet engraftment defined as achievement of a platelet count of ≥ 20 × 10⁹/L without transfusion support for at least seven consecutive days.
Time frame: 28-days
GVHD
Cumulative incidence of aGvHD and cGvHD in different target organs and overall population.
Time frame: 180 days and 2 year
Relapse
Cumulative incidence of disease relapse after transplantation.
Time frame: 1-year
Progression-free survival
Progression-free survival (PFS) after allogeneic hematopoietic cell transplantation is defined as the length of time a patient survives without evidence of disease progression or relapse following the transplantation.
Time frame: 1-year
Graft-versus-host disease (GVHD)-free, relapse-free survival (GRFS)
Graft-versus-host disease (GVHD)-free, relapse-free survival (GRFS) after allogeneic hematopoietic cell transplantation is defined as the time a patient survives without experiencing grade III-IV acute GVHD, severe chronic GVHD, relapse, or death.
Time frame: 1-year
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