Trials / Not Yet Recruiting
Not Yet RecruitingNCT06461091
the Efficacy and Safety of Total Myeloid Irradiation (TMI) in the Treatment of Adult Acute Lymphoblastic Leukemia
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
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (estimated)
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | TMI | 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). |
Timeline
- Start date
- 2024-07-01
- Primary completion
- 2025-04-30
- Completion
- 2025-04-30
- First posted
- 2024-06-14
- Last updated
- 2024-07-11
Source: ClinicalTrials.gov record NCT06461091. Inclusion in this directory is not an endorsement.