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
NCT ID: NCT06738368
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2026-01-01
2028-07-30
Brief Summary
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Detailed Description
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Patients receive etoposide intravenously (IV), doxorubicin IV and vincristine IV over 96 hours on days 1-4, cyclophosphamide IV over 1 hour on day 5, prednisone orally (PO) twice daily (BID) on days 1-5 of each cycle. In addition, CD20 positive patients receive rituximab IV on day 1 or 5 of each cycle. Patients also receive JZP458 intramuscularly (IM) once every 2-3 days on days 7-21 for up to 7 doses. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 6, 7, or 8, patients also receive pegfilgrastim subcutaneously (SC) once or filgrastim SC once daily (QD) until absolute neutrophil count (ANC) \> 2000/uL past nadir. Patients also undergo blood sample collection and bone marrow collection throughout the study. Additionally, patients with extramedullary disease may undergo computed tomography (CT) or positron emission tomography (PET)/CT throughout the study.
After completion of study treatment, patients are followed up every 3 months for 2 years then every 6 months for up to 3 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (DA-EPOCH, rituximab, JZP458)
Patients receive etoposide IV, doxorubicin IV and vincristine IV over 96 hours on days 1-4, cyclophosphamide IV over 1 hour on day 5, prednisone PO BID on days 1-5 of each cycle. In addition, CD20 positive patients receive rituximab IV on day 1 or 5 of each cycle. Patients also receive JZP458 IM every 2-3 days on days 7-21 for up to 7 doses. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 6, 7, or 8, patients also receive pegfilgrastim SC once or filgrastim SC QD until ANC \> 2000/uL past nadir. Patients also undergo blood sample collection and bone marrow collection throughout the study. Additionally, patients with extramedullary disease may undergo CT or PET/CT throughout the study.
Asparaginase Erwinia chrysanthemi
Given IM
Biospecimen Collection
Undergo blood sample collection
Bone Marrow Collection
Undergo bone marrow sample collection
Computed Tomography
Undergo CT or PET/CT
Cyclophosphamide
Given IV
Doxorubicin
Given CIV
Etoposide
Given CIV
Filgrastim
Given SC
Pegfilgrastim
Given SC
Positron Emission Tomography
Undergo PET/CT
Prednisone
Given PO
Rituximab
Given IV
Vincristine
Given CIV
Interventions
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Asparaginase Erwinia chrysanthemi
Given IM
Biospecimen Collection
Undergo blood sample collection
Bone Marrow Collection
Undergo bone marrow sample collection
Computed Tomography
Undergo CT or PET/CT
Cyclophosphamide
Given IV
Doxorubicin
Given CIV
Etoposide
Given CIV
Filgrastim
Given SC
Pegfilgrastim
Given SC
Positron Emission Tomography
Undergo PET/CT
Prednisone
Given PO
Rituximab
Given IV
Vincristine
Given CIV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In the opinion of the treating investigator, patients must be an unsuitable candidate for a pediatric-inspired regimen, reasons for which may include (but not be limited to) older age (e.g., ≥ 40 years), practical/logistical barriers to or toxicity concerns from administration of a pediatric-inspired regimen
* Marrow or blood involvement by ALL detectable by multi-parameter flow cytometry (MFC)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. (Performance status of 3 will be allowed if poor performance status is thought to be directly secondary to ALL.)
* Total bilirubin ≤ 2.0 x upper limit of normal (ULN) (unless attributed to Gilbert's disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be ≤ 4.0 x ULN) (Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is ≤ 5.0 x ULN and alanine aminotransferase \[ALT\]/aspartate aminotransferase \[AST\] are ≤ 8.0 x ULN.)
* AST (serum glutamic oxaloacetic transaminase \[SGOT\])/ALT (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 5.0 x institutional ULN. (Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is ≤ 5.0 x ULN and ALT/AST are ≤ 8.0 x ULN.)
* Calculated creatinine clearance of ≥ 60 ml/min/1.73 m\^2, as measured by the Modification of Diet in Renal Disease (MDRD) equation, will be eligible
* As patients with ALL frequently have cytopenias, no hematologic parameters will be required for enrollment or to receive the first cycle of treatment. However, adequate recovery of blood counts will be required to receive subsequent cycles
* Ability to give informed consent and comply with the protocol
* Anticipated survival of at least 3 months, independent of ALL
* Female subjects of childbearing potential should use effective non-hormonal contraceptive methods during treatment with JZP458 and for 3 months after the last dose of study drug. Male subjects with female partners of childbearing potential must agree to use an effective method of birth control from the time of signing the consent form until at least 3 months after the last dose of study drug
Exclusion Criteria
* Burkitt lymphoma/leukemia
* Isolated extramedullary or known parenchymal central nervous system (CNS) disease
* Known hypersensitivity or intolerance to any of the agents under investigation
* Known history of grade 3+ pancreatitis or chronic pancreatic insufficiency
* Known active chronic liver disease including, but not limited to, non-alcoholic steatohepatitis, cirrhosis, or non-alcoholic fatty liver disease
* Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol
* Pregnant or nursing
* Pregnancy test is only required in women, unless they are highly unlikely to conceive (defined as \[1\] surgically sterilized, or \[2\] postmenopausal \[i.e., a woman who is \> 50 years old or who has not had menses for ≥ 1 year\], or \[3\] not heterosexually active)
18 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Ryan D. Cassaday, MD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Kim Quach
Role: primary
Other Identifiers
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NCI-2024-09417
Identifier Type: REGISTRY
Identifier Source: secondary_id
FHIRB0020869
Identifier Type: OTHER
Identifier Source: secondary_id
RG1124788
Identifier Type: -
Identifier Source: org_study_id