A Single-Arm, Open-Label Phase 1b Study of Hyper-CVAD + Calaspargase Pegol in Young Adults With Newly Diagnosed Acute Lymphoblastic Leukemia
The purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.
• Pathologically confirmed Philadelphia negative B- or T-cell acute lymphoblastic leukemia, with \>10% peripheral blood or bone marrow lymphoblasts at diagnosis.
• Treatment and full recovery from arm 1A of the Hyper-CVAD regimen.
• Be willing and able to provide written informed consent/assent for the trial.
• Able to adhere to the study visit schedule and other protocol requirements.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Cardiac ejection fraction ≥ 50% by echocardiography or MUGA, as measured prior to arm 1A of Hyper-CVAD.
• Serum bilirubin and creatinine \< 1.5x upper limit of normal (ULN). AST and ALT must be \<3x ULN.
• Females of childbearing potential (FCBP) must have a negative serum pregnancy test at screening. A FCBP is considered when a sexually mature female: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months.
• A FCBP must agree to use of two methods of highly effective non-hormonal contraception, be surgically sterile, or abstain from heterosexual activity for the course of the study through 3 monthsafter the last dose of study treatment.
• Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 30 days after the last dose of study therapy. Men must agree to not donate sperm during and after the study for 3 months