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Calaspargase Pegol for Newly Diagnosed Acute Lymphoblastic Leukemia

This study is looking at how safe and tolerable the drug calaspargase pegol is when given along with standard chemotherapy (Hyper-CVAD protocol) for people with newly diagnosed acute lymphoblastic leukemia (ALL). Some patients with a specific type of ALL (CD20+ ALL) will also receive rituximab. The main goal is to see the mortality rate (death rate) of Hyper-CVAD after the first dose of calaspargase pegol, measured up to 12 months. You may be able to join if you are between 18 and 50 years old, have Philadelphia negative B- or T-cell ALL, and have completed the first part of the Hyper-CVAD treatment. The study plans to enroll 7 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 7 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured up to 12 months after the first infusion of calaspargase pegol.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05581030

CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Recruiting
PHASE1Ages 18–50InterventionalTreatment
H. Lee Moffitt Cancer Center and Research Institute
~7 participants
Updated 2026-03-06 on ClinicalTrials.gov
What's tested:Hyper CVAD Protocol (Standard of Care Multi-Agent Chemotherapy)Calaspargase PegolRituximab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mortality Rate of Hyper-CVAD after first infusion of calaspargase pegol
Measured over Up to 12 months

Conditions

Acute Lymphoblastic Leukemia

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NCT05581030

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Moffitt Cancer Center

    Tampa, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Bijal Shah, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Hannah Lewis
[email protected]
813-745-8650
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Mortality Rate of Hyper-CVAD after first infusion of calaspargase pegolUp to 12 months

    Mortality rate is hypothesized to be less than 10% when combining calaspargase pegol with Hyper-CVAD.