OncoMatch/Clinical Trials/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
Is NCT06738368 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for b acute lymphoblastic leukemia, philadelphia chromosome negative.
Treatment: Asparaginase Erwinia chrysanthemi · Cyclophosphamide · Doxorubicin · Etoposide · Filgrastim · Pegfilgrastim · Prednisone · Rituximab · Vincristine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: BCR wild-type
Ph- B-ALL
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy for ALL
Exception: 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
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
Lab requirements
Kidney function
Calculated creatinine clearance of ≥ 60 ml/min/1.73 m^2 (MDRD equation)
Liver function
Total bilirubin ≤ 2.0 x ULN (≤ 4.0 x ULN if Gilbert's disease or inherited indirect hyperbilirubinemia; ≤ 5.0 x ULN if hepatic involvement by ALL); AST/ALT ≤ 5.0 x ULN (≤ 8.0 x ULN if hepatic involvement by ALL)
Total bilirubin ≤ 2.0 x 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). 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. AST/ALT ≤ 5.0 x ULN. Calculated creatinine clearance of ≥ 60 ml/min/1.73 m^2. No hematologic parameters required for enrollment or first cycle.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
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