Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
About this trial
This is an interventional treatment trial for Precursor Cell Lymphoblastic Leukemia-Lymphoma focused on measuring Philadelphia Chromosome-Negative, Acute Lymphoblastic Leukemia, Adolescent and Adult, Pediatric-inspired Regimen, Venetoclax
Eligibility Criteria
Inclusion Criteria: De novo and primary Ph/BCR-ABL1 negative acute lymphoblastic leukemia diagnosed by the bone marrow cytomorphology, immunophenotyping, cytogenetics and molecular biology according to WHO classification Age: 14 -60 years Male or female 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: Burkitt lymphoma/leukemia Acute Leukemia of Ambiguous Lineage Female patients who are pregnant or breast feeding Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment History of pancreatitis Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of >7.5%. Patients with preexisting, well-controlled diabetes are not excluded History of active gastrointestinal bleeding within the last 6 months History of arterial/venous thrombosis within the last 6 months Known HIV seropositivity 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
Pediatric-inspired Regimen Combined With Venetoclax
Induction therapy is administered as follows:Vincristine (VCR) 1.4 mg/m2 (maximum dose 2 mg) IV on D1,8,1,5,22; Daunorubicin (DNR) 30 mg/m2/day IV on D1-3; Cyclophosphamide (CTX) 1200 mg/m2 IV on D1,15; Pegaspargase 2500u/m2 IM on D5; Prednisone 1 mg/kg/d PO on D1-14, 0.5 mg/kg/d PO on D15-28; Venetoclax 100 mg PO on D6,200 mg on D7, 400mg on D8-14, All patients underwent bone marrow aspiration on day 14 during induction. Patients with bone marrow blasts ≥10% on day 14 of induction received 7 additional days of Venetoclax on day 15-22. Consolidation therapy is a combination of multi-drug pediatric-inspired regimen chemotherapy and Venetoclax. Maintenance therapy consisted of a monthly VMMP regimen (vincristine, mercaptopurine, methotrexate, prednisone) continuing until 3 years for male and 2.5 years for female patients.