Chemotherapy + Rituximab for Acute Lymphoblastic Leukemia
Trial Summary
What is the purpose of this trial?
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.
Research Team
Ryan D. Cassaday
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Eligibility Criteria
This trial is for patients with newly diagnosed Philadelphia chromosome-negative B-acute lymphoblastic leukemia or T-ALL. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may need to have specific disease characteristics.Inclusion Criteria
Treatment Details
Interventions
- Asparaginase Erwinia chrysanthemi (Enzyme Inhibitor)
- Doxorubicin (Anti-tumor antibiotic)
- Prednisone (Corticosteroid)
- Rituximab (Monoclonal Antibodies)
Doxorubicin is already approved in Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Bladder cancer
- Lymphomas
- Leukemias
- Multiple myeloma
- Kaposi's sarcoma
- Soft tissue sarcomas
- Breast cancer
- Ovarian cancer
- Bladder cancer
- Lymphomas
- Leukemias
- Multiple myeloma
- Kaposi's sarcoma
- Soft tissue sarcomas
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Dr. Timothy H. Dellit
University of Washington
Chief Executive Officer since 2023
MD from University of Washington
Dr. Anneliese Schleyer
University of Washington
Chief Medical Officer since 2023
MD, MHA
Jazz Pharmaceuticals
Industry Sponsor
Bruce C. Cozadd
Jazz Pharmaceuticals
Chief Executive Officer since 2009
BA in Economics from Yale University, MBA from Stanford University
Dr. Austin
Jazz Pharmaceuticals
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland