Phase
Condition
Leukemia
Treatment
Vincristine
prednisone
Olverembatinib
Clinical Study ID
Ages > 14 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female patients aged 14 years or older
Newly diagnosed Philadelphia chromosome positive(either t(9;22) and/or BCR-ABLpositive and/ or FISH positive) acute lymphoblastic leukemia; Patients will bediagnosed according to morphologic,immunologic, cytogenetic and molecular(MICM)criteria, including bone marrow morphology, immunophenotype, cytogenetic andmolecular genetic (BCR/ABL gene, qualitative and quantitative analysis) examination
Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit ofnormal(ULN); serum alanine aminotransferase (ALT) and serum aspartateaminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liveris present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkalinephosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes:Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasoundejection fraction ≥ 45%;
Subject has provided written informed consent prior to any screening procedure
Exclusion
Exclusion Criteria:
Lymphoid blast crisis of chronic myelocytic leukemia (CML)
Previous or ongoing systemic anti-ALL therapy (including but not restricted to TKIand/or radiotherapy, except for appropriate pre-treatment)
Clinical manifestations of CNS or extramedullary involvement with ALL
Patients with a history of myocardial infarction within 12 months or clinicallysignificant cardiac disorders disease (e.g., unstable angina, congestive heartfailure, uncontrollable hypertension, uncontrollable arrhythmia, etc.)
Uncontrolled active serious infections that could, in the investigator's opinion,potentially interfere with the completion of treatment
Known HIV seropositivity
History of acute pancreatitis within 1 year of study screening or history of chronicpancreatitis
Uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
Female patients who are pregnant or breast feeding
Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of >7.5%. Patients with preexisting, well-controlled diabetes are not excluded
Any serious psychiatric illness that could, in the investigator's opinion,potentially interfere with the completion of treatment
Study Design
Connect with a study center
Institute of Hematology & Blood Diseases Hospital
Tianjin, 300020
ChinaSite Not Available
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