Actively Recruiting
Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Led by City of Hope Medical Center · Updated on 2026-03-17
53
Participants Needed
8
Research Sites
181 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 adults with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma. Asparaginase Erwinia chrysanthemi, a type of protein synthesis inhibitor, is a drug that is made up of the enzyme asparaginase, which comes from the bacterium Erwinia chrysanthemi, and is used with other drugs in people who cannot take asparaginase that comes from the bacterium E. coli. Asparaginase Erwinia chrysanthemi breaks down the amino acid asparagine and may stop the growth of cancer cells that need asparagine to grow. It may also kill cancer cells. Induction therapy, consisting of cytarabine, dexamethasone, vincristine, daunorubicin, methotrexate, and rituximab, is the first choice of treatment. Consolidation therapy, consisting of cyclophosphamide, cytarabine, vincristine, mercaptopurine, methotrexate and rituximab, is given after initial therapy to kill any remaining cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Cytarabine and mercaptopurine stop cells from making DNA and may kill cancer cells. They are a type of antimetabolite. Daunorubicin blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. It is a type of anthracycline antibiotic and a type of topoisomerase inhibitor. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving asparaginase Erwinia chrysanthemi with induction chemotherapy followed by consolidation chemotherapy may be safe, tolerable, and/or effective in treating high-risk adults with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma.
CONDITIONS
Official Title
Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent
- Age between 18 and 39 with BMI 30 or higher, or age 40 to 54 regardless of BMI
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia or lymphoblastic lymphoma
- Both B-cell and T-cell types allowed
- For CD20 positive patients, white blood cell count less than 25 x 10^9/L before rituximab therapy
- Total bilirubin less than or equal to 1.5 times upper limit of normal (ULN), or up to 3 times ULN if related to Gilbert's disease or leukemia
- Aspartate aminotransferase (AST) less than or equal to 3.0 times ULN (up to 5.0 times ULN if leukemia-related) before therapy and at first dose of recombinant Erwinia asparaginase
- Alanine aminotransferase (ALT) less than or equal to 3.0 times ULN (up to 5.0 times ULN if leukemia-related) before therapy and at first dose of recombinant Erwinia asparaginase
- Creatinine clearance of 60 mL/min or higher by 24-hour urine or Cockcroft-Gault formula
- Prothrombin time (PT) less than or equal to 1.5 times ULN
- Activated partial thromboplastin time (aPTT) less than or equal to 1.5 times ULN
- Left ventricular ejection fraction (LVEF) 50% or higher by echocardiogram within 42 days prior to therapy
- For CD20 positive patients, negative active hepatitis B virus tests within 28 days prior to therapy
- Women of childbearing potential with negative pregnancy test within 14 days prior to therapy
- Agreement to use effective birth control or abstain from heterosexual activity during the study and for at least 6 months after last dose (12 months if receiving rituximab)
- Childbearing potential defined as not surgically sterilized or having regular menses
You will not qualify if you...
- Prior leukemia chemotherapy except cytoreduction with steroid, hydroxyurea, or single intrathecal dose
- Prior treatment with all-trans-retinoic acid (ATRA) for suspected acute promyelocytic leukemia
- Previous treatment with any other asparaginase formulation
- Receipt or planned receipt of live vaccines during study or 2 weeks before/after treatment; CD20 patients must avoid any vaccines 4 weeks before rituximab
- Presence of Philadelphia chromosome positive disease
- Class III or IV heart failure by New York Heart Association classification (controlled atrial fibrillation allowed)
- Parenchymal central nervous system involvement
- Unstable or significant arrhythmias within 2 weeks before enrollment
- History of recent (within 6 months) acute cardiovascular ischemic events
- History of intracranial or recurrent thrombosis or severe pulmonary embolism (except catheter-related)
- History of grade 3 or higher pancreatitis
- History of alcohol overuse if relevant
- Allergic reactions to similar compounds to study drug
- Uncontrolled active infections or significant uncontrolled illnesses
- Other active cancers
- Pregnant or breastfeeding females
- Any condition or inability to comply with study procedures that may pose safety concerns
AI-Screening
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Trial Site Locations
Total: 8 locations
1
City of Hope at Phoenix
Phoenix, Arizona, United States, 85338
Actively Recruiting
2
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
3
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Not Yet Recruiting
4
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Not Yet Recruiting
5
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Not Yet Recruiting
6
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Not Yet Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Not Yet Recruiting
8
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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