This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing matched sibling donor hematopoietic stem cell transplantation (MSD-HSCT): Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI). Both regimens are supported and recommended by literature; however, there is no definitive evidence favoring one over the other. We hypothesize that the TMLI regimen, compared to the TBI regimen, may more effectively eliminate leukemia cells in the bone marrow and lymphoid tissues, thereby reducing the risk of relapse, while also minimizing damage to normal tissues, thus reducing conditioning-related toxicity and transplant-related mortality. This study aims to provide evidence for the optimal conditioning regimen for MSD-HSCT in pediatric ALL patients, with the goal of improving patient quality of life and survival outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
The total dose of TBI is 12 Gy, administered on days -7, -6, and -5, with 2 Gy per fraction, twice daily, for a total of 6 fractions.
The total dose of TMLI is 12 Gy, administered on days -7, -6, and -5, with 2 Gy per fraction, twice daily, for a total of 6 fractions.
The total dose of cyclophosphamide is 120 mg/kg, administered over 2 days on days -4 and -3.
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGRelapse-free survival (RFS)
RFS is defined as the time from transplantation to the first relapse or death, with RFS is defined as the time from transplantation to the first relapse or death, with the date of the last follow-up as the endpoint.
Time frame: 2 years
acute Graft Versus Host Disease (aGVHD)
The incidence of aGVHD within 100 days post-transplant.
Time frame: 100 days
Overall Survival (OS)
OS is defined as the time from transplantation to death, with the date of the last follow-up as the endpoint.
Time frame: 2 years
Transplantation Related Mortality (TRM)
The incidence of TRM in 2 years.
Time frame: 2 years
Relapse Rate (RR)
The incidence ratio of leukemia relapse in 2 years.
Time frame: 2 years
Conditioning-related Adverse Events (CRAE)
Based on CTCAE v5.0.
Time frame: 30 days
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