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Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Sponsor: City of Hope Medical Center
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 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.
Official title: A Phase 2 Study Evaluating the Safety and Efficacy of Asparaginase Erwinia Chrysanthemi- Recombinant-Rywn (Recombinant Erwinia Asparaginase) During Pediatric-Inspired Regimen in High-Risk Adults With Newly Diagnosed ALL or LBL
Key Details
Gender
All
Age Range
18 Years - 54 Years
Study Type
INTERVENTIONAL
Enrollment
53
Start Date
2025-10-10
Completion Date
2029-03-30
Last Updated
2026-03-17
Healthy Volunteers
No
Interventions
Asparaginase Erwinia chrysanthemi
Given IM
Biospecimen Collection
Undergo blood sample collection
Bone Marrow Aspiration
Undergo bone marrow aspiration and/or biopsy
Bone Marrow Biopsy
Undergo bone marrow aspiration and/or biopsy
Computed Tomography
Undergo CT or PET/CT
Cyclophosphamide
Given IV
Cytarabine
Given IT
Cytarabine
Given IV or SC
Daunorubicin Hydrochloride
Given IV
Dexamethasone
Given PO
Echocardiography
Undergo echocardiography
Lumbar Puncture
Undergo lumbar puncture
Mercaptopurine
Given PO
Methotrexate
Given IT
Positron Emission Tomography
Undergo PET/CT
Rituximab
Given IV
Vincristine Sulfate
Given IV
Locations (8)
City of Hope at Phoenix
Phoenix, Arizona, United States
City of Hope Medical Center
Duarte, California, United States
City of Hope at Irvine Lennar
Irvine, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States