Status:
RECRUITING
Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
Lymphoblastic Lymphoma
Eligibility:
All Genders
18-54 years
Phase:
PHASE2
Brief Summary
This phase II trial tests the safety, side effects, and effectiveness of asparaginase Erwinia chrysanthemi during induction chemotherapy followed by consolidation chemotherapy in treating high-risk ad...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability of asparaginase Erwinia chrysanthemi (asparaginase Erwinia chrysanthemi-recombinant-rywn \[recombinant Erwinia asparaginase\]; 25 mg/m\^...
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)
Key Trial Info
Start Date :
October 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2029
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT06918431
Start Date
October 10 2025
End Date
March 30 2029
Last Update
October 24 2025
Active Locations (8)
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1
City of Hope at Phoenix
Phoenix, Arizona, United States, 85338
2
City of Hope Medical Center
Duarte, California, United States, 91010
3
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
4
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093