Actively Recruiting
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
Led by University of Washington · Updated on 2026-05-12
30
Participants Needed
1
Research Sites
116 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
J
Jazz Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (age 18 years and older) with newly-diagnosed Ph- B-ALL or T-ALL
- Considered unsuitable for pediatric-inspired treatment by the doctor, possibly due to age 40 years or older or treatment concerns
- Evidence of leukemia in bone marrow or blood by specific testing
- Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2, or 3 if caused by leukemia
- Total bilirubin less than or equal to 2.0 times the upper limit of normal (ULN), or up to 4.0 times if due to inherited conditions
- AST/ALT levels less than or equal to 5.0 times institutional ULN, or up to 8.0 times if related to leukemia liver involvement
- Creatinine clearance of 60 ml/min/1.73 m2 or higher
- Ability to consent and follow the study requirements
- Expected survival of at least 3 months regardless of leukemia
- Women able to have children must use effective non-hormonal birth control during treatment and for 3 months after
- Men with female partners able to have children must use effective birth control from consent until 3 months after treatment
You will not qualify if you...
- Prior systemic therapy for ALL except limited use of corticosteroids or cytarabine for symptom control
- Diagnosis of Burkitt lymphoma or leukemia
- Leukemia only outside bone marrow or known central nervous system disease
- Known allergic reaction or intolerance to study drugs
- History of severe (grade 3 or higher) pancreatitis or chronic pancreatic problems
- Active chronic liver disease such as non-alcoholic steatohepatitis, cirrhosis, or fatty liver disease
- Other medical or psychiatric conditions that make participation unsafe
- Pregnant or nursing women
- Women not highly unlikely to conceive must have a pregnancy test before enrolling
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
K
Kim Quach
CONTACT
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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