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 human leukocyte antigen (HLA) mismatched donors. Ultimately, a HLA mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of these patients and truly enter the era of "everyone has a donor".
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 human leukocyte antigen (HLA) mismatched donors. Ultimately, a HLA mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of these patients and truly enter the era of "everyone has a donor".
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
For myeloablative conditioning: Busulfan (Bu，3.2 mg/kg/d IV -8d \~-6d) For reduced intensity conditioning: (Bu，3.2 mg/kg/d IV -7d\~-5d)
Cyclophosphamide is only used in myeloablative conditioning (Cy，1.8g/m2, -5d, -4d)
For myeloablative conditioning: Fludarabine (Flu，30 mg/m2/d IV -6d \~ -2d) For 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, China
RECRUITINGOverall survival
Overall survival after allogeneic cell transplantation refers to the length of time a patient remains alive from the date of transplantation, regardless of disease status or complications.
Time frame: 1-year
Neutrophil engraftment rate
The neutrophil engraftment rate is assessed, and neutrophil engraftment is 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
Platelet engraftment rate is assessed, and platelet engraftment is defined as achievement of a platelet count of ≥ 20 × 10⁹/L (or ≥ 50 × 10⁹/L in some definitions) without transfusion support for at least seven consecutive days.
Time frame: 28 days
Relapse
Cumulative incidence of relapse
Time frame: 1-year
Cumulative incidence of relapse
Progression-free survival after allogeneic cell transplantation refers to the length of time during which a patient remains alive without any signs of disease relapse or progression.
Time frame: 1-year
Progression free survival
Progression-free survival after allogeneic cell transplantation refers to the length of time during which a patient remains alive without any signs of disease relapse or progression.
Time frame: 1-year
GRFS
GRFS (Graft-versus-host disease-free, relapse-free survival) after allogeneic cell transplantation is the length of time a patient remains alive without experiencing significant graft-versus-host disease, disease relapse, or death.
Time frame: 1-year
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