OncoMatch/Clinical Trials/NCT06557161
A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Adult ALL
Is NCT06557161 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cyclophosphamide for acute lymphoblastic leukemia, adult.
Treatment: Cyclophosphamide — 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 adult ALL patients, with the goal of improving patient quality of life and survival outcomes.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Lab requirements
Kidney function
serum creatinine ≤ 1.5x ULN or creatinine clearance rate ≥ 60 ml/min
Liver function
ALT and AST ≤ 2.5x ULN; bilirubin ≤ 2x ULN
Cardiac function
NYHA class II or lower
Cardiac Function: NYHA class II or lower. Liver Function: ALT and AST ≤ 2.5x ULN; bilirubin ≤ 2x ULN. Renal Function: serum creatinine ≤ 1.5x ULN or creatinine clearance rate ≥ 60 ml/min. Pulmonary Function: no significant dyspnea, no oxygen therapy, no interstitial lung disease, no active pulmonary infections.
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