New enzyme combo aims to boost leukemia treatment in High-Risk adults
NCT ID NCT06918431
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a new form of the drug asparaginase (made from a different bacterium) can be safely combined with standard chemotherapy for high-risk adults aged 18–54 with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma. The treatment aims to kill cancer cells by breaking down an amino acid they need to grow. Researchers will monitor side effects and how well the cancer responds.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 53 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 54 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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) Exclusion Criteria: * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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City of Hope Medical Center
RECRUITINGDuarte, California, 91010, United States
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City of Hope at Irvine Lennar
NOT_YET_RECRUITINGIrvine, California, 92618, United States
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City of Hope at Phoenix
RECRUITINGPhoenix, Arizona, 85338, United States
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Cleveland Clinic Foundation
NOT_YET_RECRUITINGCleveland, Ohio, 44195, United States
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Memorial Sloan Kettering Cancer Center
NOT_YET_RECRUITINGNew York, New York, 10065, United States
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UC San Diego Moores Cancer Center
NOT_YET_RECRUITINGLa Jolla, California, 92093, United States
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UCLA / Jonsson Comprehensive Cancer Center
NOT_YET_RECRUITINGLos Angeles, California, 90095, United States
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University of Chicago Comprehensive Cancer Center
NOT_YET_RECRUITINGChicago, Illinois, 60637, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a Chemo-Antibody combo beat a tough leukemia?
- Can a smart drug missile tame Hard-to-Treat leukemia?
- Personalized chemo dosing may boost survival in kids with High-Risk leukemia
- Engineered immune cells take aim at Hard-to-Treat T-Cell cancers