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

Not yet recruiting

• Conditions: Acute Lymphoblastic Leukemia

• Registration Number: NCT06461091
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief 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.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-13
• Study First Submitted QC: 2024-06-11
• Study First Posted: 2024-06-14
• Study Start: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-11
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS).	1YEAR	Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS).

Secondary Outcome Measures

Name	Time	Method
(2) Incidence of toxicity related to the conditioning regimen.	1YEAR	(2) Incidence of toxicity related to the conditioning regimen.
(1) Rate of granulocyte and platelet hematopoietic recovery.	1YEAR	(1) Rate of granulocyte and platelet hematopoietic recovery.