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DA-EPOCH with or without Rituximab Plus JZP458 for ALL

This study is testing a treatment combination for adults (18 and older) newly diagnosed with Philadelphia chromosome negative B-acute lymphoblastic leukemia (B-ALL) or T-acute lymphoblastic leukemia (T-ALL). This treatment includes chemotherapy drugs like etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH), with or without rituximab, plus recombinant Erwinia asparaginase (JZP458). Rituximab is a monoclonal antibody, which is a type of protein that can block the growth of cancer cells. The main goal is to see how many patients achieve measurable residual disease (MRD) negativity after four cycles of treatment. This means checking if there are any cancer cells left that are too small to be seen under a microscope. The study is currently recruiting about 30 participants, but its overall status is unclear.

Study design
This is an interventional study, but the phase is not specified. It plans to enroll 30 participants.
What's involved
You would receive treatment cycles every 21 days for up to 8 cycles. This involves intravenous (IV) and oral medications, and intramuscular (IM) injections. You will also have blood and bone marrow samples collected, and potentially CT or PET/CT scans if you have disease outside the bone marrow.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you will be followed up every 3 months for 2 years, then every 6 months for up to 3 years.

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NCT06738368

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Washington
~30 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Asparaginase Erwinia chrysanthemiBiospecimen CollectionBone Marrow CollectionComputed TomographyCyclophosphamideDoxorubicin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measurable residual disease (MRD) negativity
Measured over After 4 cycles of treatment (cycle length = 21 days)

Conditions

B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
T Acute Lymphoblastic Leukemia

Explore related trials

B Acute Lymphoblastic LeukemiaPre T-ALL

Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Ryan D. Cassaday, MD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Kim Quach
[email protected]
206-606-8311
Email the study team

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Eligibility criteria

Inclusion

Adults (age 18 years and older) with newly-diagnosed Ph- B-ALL or T-ALL
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

Prior systemic therapy for ALL except to control acute symptoms and/or leukocytosis (e.g., corticosteroids, cytarabine, etc.). Cytarabine 500 mg/m\^2 per dose up to 2 doses and/or the equivalent of prednisone 50 mg/m\^2/day for up to 2 days are permitted
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)

What this trial measures

  • Measurable residual disease (MRD) negativityAfter 4 cycles of treatment (cycle length = 21 days)

    Will be measured by multi-parameter flow cytometry (MFC). Will be assessed according to the National Comprehensive Cancer Network response criteria.