RecruitingPhase 2NCT06738368

Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia

Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) ± Rituximab + Recombinant Erwinia Asparaginase (JZP458; Rylaze®) for the Treatment of Newly-Diagnosed Adults With Philadelphia Chromosome-Negative Acute Lymphoblastic Lymphoma/Leukemia


Sponsor

University of Washington

Enrollment

30 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin (DA-EPOCH) with or without rituximab plus recombinant Erwinia asparaginase (JZP458) works in treating patients with newly diagnosed Philadelphia chromosome (Ph) negative B-acute lymphoblastic leukemia (ALL) or T-ALL. Chemotherapy drugs, such as etoposide, vincristine, cyclophosphamide and doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. 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. JZP458 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving DA-EPOCH with or without rituximab plus JZP458 may kill more cancer cells in patients with newly diagnosed Ph negative B-ALL or T-ALL.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a chemotherapy combination called DA-EPOCH (with or without rituximab) plus a drug called recombinant Erwinia asparaginase for adults with newly diagnosed acute lymphoblastic leukemia (ALL) — a fast-growing blood cancer. It is designed for adult patients who are not good candidates for the more intensive pediatric-type treatment regimens. **You may be eligible if...** - You are 18 or older and have been newly diagnosed with Philadelphia chromosome-negative B-cell or T-cell ALL - Your doctor considers you unsuitable for a pediatric-inspired regimen (for example, due to older age or health concerns) - Leukemia cells are detectable in your blood or bone marrow - You are well enough to receive treatment **You may NOT be eligible if...** - You have Philadelphia chromosome-positive ALL - You have already received treatment for this leukemia - You have conditions that would make this chemotherapy regimen unsafe 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 Collection

Undergo bone marrow sample collection

PROCEDUREComputed Tomography

Undergo CT or PET/CT

DRUGCyclophosphamide

Given IV

DRUGDoxorubicin

Given CIV

DRUGEtoposide

Given CIV

BIOLOGICALFilgrastim

Given SC

BIOLOGICALPegfilgrastim

Given SC

PROCEDUREPositron Emission Tomography

Undergo PET/CT

DRUGPrednisone

Given PO

BIOLOGICALRituximab

Given IV

DRUGVincristine

Given CIV


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06738368


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