To study the minimal residual disease (MRD) clearance rate of olverembatinib combined with inotuzumab ozogamicin as first-line consolidation chemotherapy in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) who have not achieved MRD remission after initial induction chemotherapy.
(1) Clearly diagnosed acute lymphoblastic leukemia, with Philadelphia chromosome positivity or BCR-ABL fusion gene positivity; with CD22 expression on the surface of leukemia cells; failure to achieve minimal residual disease (MRD) negativity after first induction chemotherapy (BCR-ABL fusion gene level ≥ 10-⁴), where the induction regimen is standard chemotherapy combined with any tyrosine kinase inhibitor targeting BCR-ABL1.
(2) Age greater than or equal to 18 years.
(3) Able to provide informed consent independently.
(4) Must have adequate organ function: renal and hepatic functions as follows: AST, ALT, and ALP less than 2 times the upper limit of normal (ULN), total bilirubin less than 1.5 times ULN; creatinine clearance greater than 50 mL/min; pancreatic function: serum amylase not exceeding 1.5 times ULN, serum lipase not exceeding 1.5 times ULN; normal cardiac function: ejection fraction (EF) > 60%, pulmonary artery systolic pressure ≤ 50 mmHg.
(1) Mixed lineage leukemia;
(2) Involvement of the central nervous system or extramedullary infiltration;
(3) Patients with concurrent other malignancies; or those assessed by the investigator as having concomitant diseases that severely endanger the patient's life or affect the completion of the study;
(4) Patients with severe allergy to the components or excipients of InO (≥ Grade 3);