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

• Status: NOT_YET_RECRUITING
• Trial end date: 2028-06-30

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.

• Phase: PHASE2

Details

• Lead Sponsor: University of Washington
• Collaborator: Jazz Pharmaceuticals
• Treatments: Asparaginase; asparaginase erwinia chrysanthemi recombinant; CT-P10; Cyclophosphamide; deltacortene; Doxorubicin; Etoposide; Filgrastim; Granulocyte Colony-Stimulating Factor; Magnetic Resonance Spectroscopy; pegfilgrastim; pegylated granulocyte colony-stimulating factor; Prednisone; prednylidene; Rituximab; Specimen Handling; Vincristine