This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing haploidentical allogeneic hematopoietic stem cell transplantation (haplo-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 haplo-HSCT in adult ALL patients, with the goal of improving patient quality of life and survival outcomes.
Informed Consent: Participants must voluntarily sign a written informed consent form.
Age and Gender: Participants should be male or female, aged 18-65 years, inclusive.
Diagnosis: Participants must be diagnosed with acute lymphoblastic leukemia (ALL) according to World Health Organization (WHO) criteria, and the diagnosis must apply to adults aged 18-65 years.
Remission Status: The participant's leukemia must be in hematologic remission (complete remission, CR) prior to transplantation.
The patient has not achieved hematologic remission before transplantation.
The patient has chosen a non-haploidentical related donor.
The patient has severe cardiac, hepatic, renal, or pulmonary diseases that make them unable to tolerate the conditioning regimen.
The patient has an active or refractory infection, or other life-threatening complications.
Parallel
TBI
RadiationThe 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.
TMLI
RadiationThe 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.
Cyclophosphamide
DrugThe total dose of cyclophosphamide is 120 mg/kg, administered over 2 days on days -4 and -3.
Relapse-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.
acute Graft Versus Host Disease (aGVHD)
The incidence of aGVHD within 100 days post-transplant.
Overall Survival (OS)
OS is defined as the time from transplantation to death, with the date of the last follow-up as the endpoint.
Transplantation Related Mortality (TRM)
The incidence of TRM in 2 years.
Relapse Rate (RR)
The incidence ratio of leukemia relapse in 2 years.
Conditioning-related Adverse Events (CRAE)
Based on CTCAE v5.0.
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