A Phase 1 Study Combining Venetoclax With a Pediatric-Inspired Regimen for Newly Diagnosed Adults With B Cell Ph-Like Acute Lymphoblastic Leukemia
This phase I trial tests the safety, side effects, and best dose of venetoclax in combination with a pediatric-inspired chemotherapy regimen known as C10403 in treating patients with newly diagnosed B cell acute lymphoblastic leukemia. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. The C10403 regimen is composed of the chemotherapy drugs cytarabine, cyclophosphamide, daunorubicin, mercaptopurine, pegaspargase, vincristine, and methotrexate, all which work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It also consists of prednisone, which is an anti-inflammatory drug that lowers the body's immune response and is used with other drugs in the treatment of some types of some types of cancer. This study may help researchers learn if adding venetoclax to the pediatric-inspired C10403 regimen can be tolerated and help treat older patients.
• Documented informed consent of the participant and/or legally authorized representative
• Age between 18 and 54 years
• Eastern Cooperative Oncology Group (ECOG) =\< 2
• Histologically confirmed B-cell ALL according to World Health Organization criteria
⁃ Note: Lymphoblastic leukemia is included as long as there is bone marrow involvement
• Newly diagnosed disease with \>= 5% blasts in the marrow
• White blood cell count less than 25 x 10\^9/L prior to initiation of venetoclax. Cytoreduction with hydroxyurea or steroid or a single dose of intrathecal chemotherapy prior to treatment may be required (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
• Total bilirubin =\< 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease or underlying leukemia, =\< 3 X ULN) (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
• Aspartate aminotransferase (AST) =\< 2.5 x ULN (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
⁃ Unless it is related to underlying leukemia
• Alanine aminotransferase (ALT) =\< 2.5 x ULN (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
⁃ Unless it is related to underlying leukemia
• Creatinine clearance of \>= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
• Left ventricular ejection fraction (LVEF) \>= 50%
⁃ Note: Echocardiogram to be performed within 42 days prior to day 1 of protocol therapy
• Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test. (performed within 14 days prior to Day 1 of protocol therapy unless otherwise stated)
⁃ If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• Agreement by females and males of childbearing potential\* to use an effective method of birth control (non-hormonal) or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy
⁃ Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only