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Observation of event-free survival, engraftment rate, overall survival (OS), and safety data in patients aged ≥16 years with acute lymphoblastic leukemia (ALL) receiving a conditioning regimen including total marrow irradiation (TMI) followed by allogeneic hematopoietic stem cell transplantation. Aim to further enhance transplant outcomes in ALL patients based on the existing basis.
Observation of event-free survival, engraftment rate, overall survival (OS), and safety data in patients aged ≥16 years with acute lymphoblastic leukemia (ALL) receiving a conditioning regimen including total marrow irradiation (TMI) followed by allogeneic hematopoietic stem cell transplantation. Aim to further enhance transplant outcomes in ALL patients based on the existing basis.Exploratory Endpoint: Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS).Secondary Exploratory Endpoints: (1) Rate of granulocyte and platelet hematopoietic recovery. (2) Incidence of toxicity related to the conditioning regimen.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMI | Radiation | Observing the efficacy and safety of allogeneic hematopoietic stem cell transplantation in treating adult acute lymphoblastic leukemia with a conditioning regimen including total marrow irradiation (TMI) in individuals aged 16 years and older: Primary Exploratory Endpoint: Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS). |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS). | Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS). | 1YEAR |
| Measure | Description | Time Frame |
|---|---|---|
| (1) Rate of granulocyte and platelet hematopoietic recovery. | (1) Rate of granulocyte and platelet hematopoietic recovery. | 1YEAR |
| (2) Incidence of toxicity related to the conditioning regimen. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients( aged ≥16 years) with acute lymphoblastic leukemia (ALL) paining to receive allogeneic hematopoietic stem cell transplantation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| erlie jiang | Contact | +86-15122538106 | jiangerlie@ihcams.ac.cn | |
| yigeng cao | Contact | +86-18622477066 | caoyigeng@ams.ac.cn |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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(2) Incidence of toxicity related to the conditioning regimen.
| 1YEAR |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |