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Asparaginase Erwinia Chrysanthemi with Chemotherapy for High-Risk ALL/LBL

This study is testing the safety and effectiveness of asparaginase Erwinia chrysanthemi given with chemotherapy for adults with newly diagnosed acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL). Asparaginase Erwinia chrysanthemi is a drug that helps stop the growth of cancer cells by breaking down a substance called asparagine, which some cancer cells need to grow. This trial is for adults aged 18 to 54 who have high-risk ALL or LBL that is Philadelphia chromosome negative. Researchers will be looking at side effects and how well the treatment works to achieve remission. The study plans to enroll 53 participants, but its current status is unclear.

Study design
This is an interventional study that plans to enroll 53 participants. It is testing a specific drug combination for a particular type of cancer.
What's involved
You would undergo procedures like blood sample collection, bone marrow aspiration and/or biopsy, and CT or PET/CT scans. The primary safety evaluations will occur up to the completion of the induction cycle, which is 28 days.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured up to the completion of the induction cycle, which lasts 28 days.

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

NCT06918431

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

Recruiting
PHASE2Ages 18–54InterventionalTreatment
City of Hope Medical Center
~53 participants
Updated 2026-03-17 on ClinicalTrials.gov
What's tested:Asparaginase Erwinia chrysanthemiBiospecimen CollectionBone Marrow AspirationBone Marrow BiopsyComputed TomographyCyclophosphamide

At a glance

Recruiting sites
2 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs) (Safety Lead-in)
Measured over Up to completion of induction cycle (cycle length = 28 days)
+2 more outcomes measured

Conditions

B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
Lymphoblastic Lymphoma

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Where it's being run

8 sites across 5 states
California4
Arizona1
Illinois1
New York1
Ohio1

Study leadership

  • Ibrahim Aldoss · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Tibor Kovacsovics, MD
[email protected]
888-256-0250
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Incidence of adverse events (AEs) (Safety Lead-in)Up to completion of induction cycle (cycle length = 28 days)

    Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Will be summarized for evaluable patients in terms of type (organ affected or laboratory determination), severity, time of onset, duration, frequency, probable association with the study treatment and reversibility or outcome.

  • Incidence of unacceptable adverse events (Safety Lead-in)Up to completion of induction cycle 1 (cycle length = 28 days)

    Will be summarized for evaluable patients in terms of type (organ affected or laboratory determination), severity, time of onset, duration, frequency, probable association with the study treatment and reversibility or outcome.

  • 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)

    Will be graded using NCI CTCAE v 5.0. Will be summarized for evaluable patients in terms of type (organ affected or laboratory determination), severity, time of onset, duration, frequency, probable association with the study treatment and reversibility or outcome. The overall rate and its 95% Clopper Pearson binomial confidence interval (CI) will be estimated.