RecruitingPhase 2NCT06918431

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

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


Sponsor

City of Hope Medical Center

Enrollment

53 participants

Start Date

Oct 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 54 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a chemotherapy regimen that includes asparaginase erwinia chrysanthemi (a specific type of enzyme-based drug) in combination with other chemotherapy for high-risk adults with newly diagnosed acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL). **You may be eligible if...** - You are between 18 and 39 years old with a BMI of 30 or above, OR between 40 and 54 years old (regardless of BMI) - You have been newly diagnosed with Philadelphia chromosome-negative ALL or lymphoblastic lymphoma - Your general health status is acceptable (ECOG 0-2) - Your liver function is within acceptable ranges **You may NOT be eligible if...** - You have previously been treated for ALL or LBL - You carry the Philadelphia chromosome (a specific genetic change in the cancer) - Your leukemia is very aggressive with an extremely high white blood cell count that cannot be managed before treatment starts Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAsparaginase Erwinia chrysanthemi

Given IM

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration and/or biopsy

PROCEDUREBone Marrow Biopsy

Undergo bone marrow aspiration and/or biopsy

PROCEDUREComputed Tomography

Undergo CT or PET/CT

DRUGCyclophosphamide

Given IV

DRUGCytarabine

Given IT

DRUGCytarabine

Given IV or SC

DRUGDaunorubicin Hydrochloride

Given IV

DRUGDexamethasone

Given PO

PROCEDUREEchocardiography

Undergo echocardiography

PROCEDURELumbar Puncture

Undergo lumbar puncture

DRUGMercaptopurine

Given PO

DRUGMethotrexate

Given IT

PROCEDUREPositron Emission Tomography

Undergo PET/CT

BIOLOGICALRituximab

Given IV

DRUGVincristine 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

View Full Details on ClinicalTrials.gov

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NCT06918431


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