Acute Lymphoblastic Leukemia Clinical Trial
— TMIOfficial title:
A Prospective, Single-arm, Exploratory Clinical Study of the Efficacy and Safety of Total Myeloid Irradiation (TMI) in the Treatment of Adult Acute Lymphoblastic Leukemia
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.
| Status | Not yet recruiting |
| Enrollment | 20 |
| Est. completion date | April 30, 2025 |
| Est. primary completion date | April 30, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years and older |
| Eligibility | Inclusion Criteria: - Subjects eligible for inclusion in this study must meet all of the following criteria: (1) Definitive diagnosis of acute lymphoblastic leukemia requiring allogeneic hematopoietic stem cell transplantation. (2) Age greater than or equal to 16 years. Exclusion Criteria: - Subjects meeting any of the following criteria are not eligible for inclusion in this study: (1) Patients with extramedullary infiltration (excluding central nervous system leukemia). (2) Patients undergoing second transplantation. (3) Patients with concurrent malignancies. (4) Patients with malignancies secondary to a second tumor. (5) Patients assessed by the investigator to have accompanying diseases that are deemed to pose a serious risk to the patient's life or interfere with the patient's completion of this study. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Institute of Hematology & Blood Diseases Hospital, China |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | (1) Rate of granulocyte and platelet hematopoietic recovery. | (1) Rate of granulocyte and platelet hematopoietic recovery. | 1YEAR | |
| Secondary | (2) Incidence of toxicity related to the conditioning regimen. | (2) Incidence of toxicity related to the conditioning regimen. | 1YEAR |
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