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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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLA-mismatch related | Experimental | The myeloablative conditioning is used when the patient is below 50 and with an HCT-CI<2. The reduced intensity conditioning is used when the patient is over 50 or with an HCT-CI≥2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Busulfan (Busulfex) | Drug | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall 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. | 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 28 days |
| Platelet engraftment rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanmin Zhao, MD., PhD | Contact | +86 87236706 | yanminzhao@zju.edu.cn | |
| Yishan Ye, MD., PhD | Contact | yeyishan@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | China | 310003 | China |
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| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D012673 | Semustine |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Cyclophosphamide (CTX) | Drug | Cyclophosphamide is only used in myeloablative conditioning (Cy，1.8g/m2, -5d, -4d) |
|
| Fludarabine (Fludara) | Drug | For myeloablative conditioning: Fludarabine (Flu，30 mg/m2/d IV -6d ~ -2d) For reduced intensity conditioning: Fludarabine（Flu，30mg/m2 /d IV -10d~-5d） |
|
| Semustine (MeCCNU) | Drug | For both myeloablative and reduced intensity conditioning: Semustine (MECCNU，250 mg/m2 orally-3d). |
|
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.
| 28 days |
| Relapse | Cumulative incidence of relapse | 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. | 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. | 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. | 1-year |
| D008698 |
| Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D008130 | Lomustine |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009603 | Nitroso Compounds |