NCT05581030 · H. Lee Moffitt Cancer Center and Research Institute
CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
What this study is about
The purpose of the study is to evaluate the safety and how well patients handle the treatment of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.
View original scientific description
The purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.
Interventions
DRUG
Hyper CVAD Protocol (Standard of Care Multi-Agent Chemotherapy)
Hyper-CVAD consists of two combinations of drugs (courses A and B) given in an alternating fashion. The term "hyper" refers to the hyperfractionated nature of the chemotherapy, which is given in small doses, more frequently, to minimize side effects. CVAD is the acronym of the drugs in course a: cyclophosphamide, vincristine, doxorubicin and dexamethasone. Course A: Cyclophosphamide days 1, 2 and 3. Vincristine days 4 and 11, Doxorubicin day 4, dexamethasone days 1-4 and 11-14, Cytarabine day 7. Mesna is also given orally with cyclophosphamide, to reduce the incidence of haemorrhagic cystitis, a common side effect of cyclophosphamide. Methotrexate, an antimetabolite, may be given when necessary to get chemotherapy past the blood brain barrier. Course B: Methotrexate Day 1 and Cytarabine Days 2 and 3. Dosage is individualized to the patient.
DRUG
Calaspargase Pegol
Calaspargase pegol 2000 IU/m\^2 (capped at 3750 IU) will be administered beginning in cycle 1B of Hyper-CVAD, and will continue at this dose for the duration of the trial.
DRUG
Rituximab
Rituximab 375mg/m\^2 will be administered once per cycle for patients with CD20+ ALL.
Primary outcome measures
Mortality Rate of Hyper-CVAD after first infusion of calaspargase pegol
Time frame: Up to 12 months
Mortality rate is hypothesized to be less than 10% when combining calaspargase pegol with Hyper-CVAD.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Tampa, Florida
Collaborators
Servier
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 6, 2026 · Source of record for eligibility and locations