Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax for de Novo Ph+ ALL
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
About this trial
This is an interventional treatment trial for Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Eligibility Criteria
Inclusion Criteria:
- Male or female patients aged 14 years or older
- Newly diagnosed Philadelphia chromosome positive(either t(9;22) and/or BCR-ABL positive and/ or FISH positive) acute lymphoblastic leukemia; Patients will be diagnosed according to morphologic,immunologic, cytogenetic and molecular(MICM) criteria, including bone marrow morphology, immunophenotype, cytogenetic and molecular 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 of normal(ULN); serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection fraction ≥ 45%;
- Subject has provided written informed consent prior to any screening procedure
Exclusion Criteria:
- Lymphoid blast crisis of chronic myelocytic leukemia (CML)
- Previous or ongoing systemic anti-ALL therapy (including but not restricted to TKI and/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 clinically significant cardiac disorders disease (e.g., unstable angina, congestive heart failure, 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 chronic pancreatitis
- 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
Sites / Locations
- Institute of Hematology & Blood Diseases HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax
For Induction cycle, olverembatinib will be given orally 40mg every other day. Patients with CMR, olverembatinib will be reduced to 30 mg every other day. Induction and consolidation cycles combined with a certain period of venetoclax. Reduced-intensity chemotherapy regimens consist mainly of vincristine and prednisone. Patients can receive allogeneic hematopoietic stem cell transplantation (HSCT),or patients who keep BCR/ABL negative can receive autologous HSCT whenever possible during their first CR. Otherwise, they will finish the consolidation chemotherapy.