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NCT06461091 Clinical Trial

the Efficacy and Safety of Total Myeloid Irradiation (TMI) in the Treatment of Adult Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia Clinical Trial

— TMI  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06461091
Other study ID # IIT2024023
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date April 30, 2025

Study information
Verified date May 2024
Source Institute of Hematology & Blood Diseases Hospital, China
Contact erlie jiang
Phone +86-15122538106
Email jiangerlie@ihcams.ac.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
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.

Study Design

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Institute of Hematology & Blood Diseases Hospital, China

Outcome
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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