Phase 2 Study of DA-EPOCH Chemotherapy With or Without Rituximab Plus Recombinant Erwinia Asparaginase JZP458 for Adults Newly Diagnosed With Philadelphia Chromosome-Negative B- or T-Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating a combination chemotherapy regimen called DA-EPOCH with or without rituximab plus recombinant Erwinia asparaginase JZP458 in adults newly diagnosed with Philadelphia chromosome-negative B-acute lymphoblastic leukemia B-ALL or T-ALL. This phase II trial aims to understand how well these treatments work together to stop the growth of leukemia cells by targeting them through different mechanisms, including immune system involvement and enzyme blocking. Participants receive etoposide, doxorubicin, and vincristine intravenously over four days, cyclophosphamide intravenously on day five, and prednisone orally twice daily during the first five days of each 21-day cycle. Those with CD20-positive disease also receive rituximab intravenously on day one or five. JZP458 is given intramuscularly every 2 to 3 days from days 7 to 21 for up to seven doses. Patients receive up to eight cycles of treatment if there is no disease progression or unacceptable side effects. Starting between days 6 and 8, participants receive pegfilgrastim or filgrastim subcutaneously to support white blood cell counts. Blood and bone marrow samples are collected throughout the study, and imaging such as CT or PETCT may be done for those with extramedullary disease. During the study, patients undergo regular monitoring including blood tests, bone marrow collections, and imaging when applicable. After finishing treatment, follow-up visits occur every three months for two years and then every six months for up to three more years to assess outcomes such as measurable residual disease and survival. The study monitors safety through adverse event reporting and evaluates long-term effects up to five years. Total participation may last several years due to the extended follow-up period.

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