Clinical Trial 21213

• Overview

  Study Title:

  A Single-Arm, Open-Label Phase 1b Study of Hyper-CVAD + Calaspargase pegol in Young Adults with Newly Diagnosed Acute Lymphoblastic Leukemia

  Summary:

  The purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.

  Objective:

  1. To estimate the safety and tolerability of treatment with Calaspargase pegol given with multiagent chemotherapy; 2. To estimate response, inclusive of minimal residual disease; 3. To estimate the duration of response (DOR), event free survival (EFS), and overall survival (OS).

• Treatments

  Therapies:

  Chemotherapy (NOS)

  Medications:

  Calaspargase pegol ()

• Inclusion Criteria

  Inclusion Criteria:
  • 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 > 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
  • Additional criteria may apply

• Exclusion Criteria

  Exclusion Criteria:
  • Induction therapy with any regimen other than Hyper-CVAD 1A.
  • Diagnosis of L3 type Burkitt's lymphoma
  • Clinical evidence of active central nervous system (CNS) leukemia.
  • Any major surgery or radiation therapy within four weeks.
  • Diagnosis of Down Syndrome.
  • Any active infection requiring systemic therapy, including HIV, Hepatitis B, and/or Hepatitis C.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator (including but not limited to unstable angina, pre-existing liver disease, recurrent pancreatitis, uncontrolled diabetes, hypertriglyceridemia, pulmonary hypertension, or severeheart failure (New York Heart Association Class III-IV).
  • Recurrent thrombosis, or non-central venous catheter associated thrombosis within 3 months prior to enrollment.
  • Severe comorbid conditions for which life expectancy would be > Patients with active (uncontrolled, metastatic) second malignancies are excluded.
  • Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 3 months after the last dose of trial treatment.
  • Other exclusions may apply

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