CalPeg treatment for newly diagnosed acute lymphoblastic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and tolerability of calaspargase pegol when combined with standard multi-agent chemotherapy for patients with newly diagnosed acute lymphoblastic leukemia (ALL). Participants will receive the Hyper CVAD protocol alongside calaspargase pegol and rituximab. The study aims to determine how well this combination works and its side effects in treating ALL. It is a Phase 1 interventional trial focusing on patients with specific eligibility criteria.

Why it matters

Who can join: the full rules

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 \< 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

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 \<6 months.
* 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.

Where it's running

• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Bijal Shah, MD — Moffitt Cancer Center

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.