Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to 54 Years
• SexAll
• Healthy volunteersNo

You may be able to join if

• Documented informed consent of the participant and/or legally authorized representative
• Age between 18 and 39 with body mass index (BMI) ≥ 30 or age 40-54 years, regardless of BMI
• Eastern Cooperative Oncology Group (ECOG) ≤ 2
• Patients with newly diagnosed Philadelphia (Ph)-negative (-) acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) according to World Health Organization (WHO) criteria
• Both B- and T-cell phenotypes are allowed.
• CD20+ patients only: White blood cell count less than 25 x 10^9/L prior to initiation of rituximab (within 14 days prior to day 1 of protocol therapy)
• Cytoreduction with hydroxyurea or steroid or a single dose of intrathecal chemotherapy prior to treatment may be required
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 14 days prior to day 1 of protocol therapy) (unless has Gilbert's disease or related to underlying leukemia, ≤ 3 x ULN)
• Aspartate aminotransferase (AST) ≤ 3.0 x ULN (AST ≤ 5.0 x ULN if related to underlying leukemia) (within 14 days prior to day 1 of protocol therapy)
• Note: AST ≤ 3.0 x ULN at the time of first dose of recombinant Erwinia asparaginase administration
• Alanine aminotransferase (ALT) ≤ 3.0 x ULN (ALT ≤ 5.0 x ULN if related to underlying leukemia) (within 14 days prior to day 1 of protocol therapy)
• Note: ALT ≤ 3.0 x ULN at the time of first dose of recombinant Erwinia asparaginase administration
• Creatinine clearance of ≥ 60 mL/min per 24-hour urine test or the Cockcroft-Gault formula (within 14 days prior to day 1 of protocol therapy)
• Prothrombin (PT) ≤ 1.5 ULN (within 14 days prior to day 1 of protocol therapy)
• Activated partial thromboplastin time (aPTT) ≤ 1.5 ULN (within 14 days prior to day 1 of protocol therapy)
• Left ventricular ejection fraction (LVEF) ≥ 50%
• Note: Echocardiogram to be performed within 42 days prior to day 1 of protocol therapy
• Seronegative for active hepatitis B virus (HBV) (surface antigen negative and anti-hepatitis B virus core antibody [HBc] negative) for CD20+ patients only
• Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
• Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 14 days prior to day 1 of protocol therapy)
• If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• Agreement by females and males of childbearing potential to use an effective (non-hormonal) method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy. For participants taking rituximab, effective birth control or abstinence to be used for at least 12 months after last dose
• Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

You cannot join if

• Leukemia-based therapy with chemotherapy with the exception of:
• Cytoreduction with steroid or hydroxyurea or a single dose of intrathecal chemotherapy is allowed before initiating the study
• Prior treatment with all-trans-retinoic acid (ATRA) for suspected acute promyelocytic leukemia (APL) is allowed
• Received previous treatment with any other asparaginase formulation
• Must not have received or planning to receive live vaccine while being on study or 2 weeks before and after completion of treatment. For CD20+ patients only: Must not have received any vaccines (live or non-live) 4 weeks before rituximab
• Known presence of Philadelphia chromosome positive (Ph+; t[9;22])
• Class III/IV cardiovascular disability according to the New York Heart Association classification. Subjects with controlled, asymptomatic atrial fibrillation can enroll
• Parenchymal central nervous system (CNS) involvement
• Participants with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of enrollment
• History of acute cardiovascular ischemic event, i.e., myocardial infarction or unstable angina within 6 months of enrollment
• History of intracranial thrombosis or history of recurrent thrombosis or grade 3 and greater pulmonary embolism (except for catheter-related thrombosis)
• Participants with history of grade ≥ 3 pancreatitis
• History of alcohol overuse if deemed relevant in investigator opinion
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
• Uncontrolled active infection
• Clinically significant uncontrolled illness
• Other active malignancy
• Females only: Pregnant or breastfeeding
• Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
• Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• Asparaginase Erwinia chrysanthemi (Drug): Given IM
• Biospecimen Collection (Procedure): Undergo blood sample collection
• Bone Marrow Aspiration (Procedure): Undergo bone marrow aspiration and/or biopsy
• Bone Marrow Biopsy (Procedure): Undergo bone marrow aspiration and/or biopsy
• Computed Tomography (Procedure): Undergo CT or PET/CT
• Cyclophosphamide (Drug): Given IV
• Cytarabine (Drug): Given IT
• Cytarabine (Drug): Given IV or SC
• Daunorubicin Hydrochloride (Drug): Given IV
• Dexamethasone (Drug): Given PO
• Echocardiography (Procedure): Undergo echocardiography
• Lumbar Puncture (Procedure): Undergo lumbar puncture
• Mercaptopurine (Drug): Given PO
• Methotrexate (Drug): Given IT
• Positron Emission Tomography (Procedure): Undergo PET/CT
• Rituximab (Biological): Given IV
• Vincristine Sulfate (Drug): Given IV

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• biopsy: Part of the study plan
• bone marrow: Part of the study plan
• blood samples: Part of the study plan
• CT scans: Part of the study plan
• PET scans: Part of the study plan
• echocardiogram: Part of the study plan
• lumbar puncture: Part of the study plan

Main goals

• Incidence of adverse events (AEs) (Safety Lead-in) (Up to completion of induction cycle (cycle length = 28 days))
• Incidence of unacceptable adverse events (Safety Lead-in) (Up to completion of induction cycle 1 (cycle length = 28 days))
• Incidence of grade 3 or higher hepatotoxicity and not resolved to grade 1 or lower within 14 days of occurrence (Expansion) (Up to completion of induction (cycle length = 28 days))

Other goals

• Incidence of AEs (Expansion cohort only)
• Composite complete response (CR)
• CR rate
• Minimal residual disease (MRD) negativity
• MRD negativity
• Proportion of patients to receive extended induction/consolidation/salvage therapy
• Incidence of grade 3 or higher hepatotoxicity
• Nadir serum asparaginase activity (NSAA)
• Duration of grade 3 or higher hepatotoxicity

Planned enrollment: 53 (estimated).

• City of Hope at Phoenix, Phoenix, Arizona
• City of Hope Medical Center, Duarte, California
• City of Hope at Irvine Lennar, Irvine, California
• University of Chicago Comprehensive Cancer Center, Chicago, Illinois

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT06918431

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 12, 2026. Public record; not medical advice.