This phase II trial studies how well etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin (DA-EPOCH) works in treating patients with acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03023046.
PRIMARY OBJECTIVE:
I. To examine the potential efficacy of DA-EPOCH as front-line therapy for adults with acute lymphoblastic leukemia/lymphoma (ALL).
SECONDARY OBJECTIVES:
I. To evaluate the safety and feasibility of this regimen.
II. To evaluate the progression-free (PFS) and overall survival (OS) of patients after receiving DA-EPOCH for newly-diagnosed ALL.
EXPLORATORY OBJECTIVES:
I. To explore for novel genetic/genomic biomarkers of prognosis and response to treatment in adults with ALL.
II.To compare outcomes predicted by the presence or absence of minimal residual disease (MRD) as determined by either multiparameter flow cytometry (MFC) or high-throughput sequencing (HTS).
OUTLINE:
Patients receive etoposide intravenously (IV) over 96 hours, doxorubicin IV over 96 hours, and vincristine sulfate IV over 96 hours on days 1-4. Patients also receive cyclophosphamide IV over 1 hour on day 5 and prednisone orally (PO) twice a day (BID) on days 1-5. Patients with disease features that predict sensitivity to ABL kinase inhibitors (e.g., Philadelphia Chromosome positive (Ph+) [i.e., t(9;22)]; rearrangements involving PDGFRA, PDGFRB, ABL2, or other genetic lesions that activate kinase receptor signaling) receive imatinib mesylate or dasatinib PO once per day (QD) on days 1-14. The decision to add imatinib or dasatinib will be left to the treating physician and will be based on the available scientific literature to support the sensitivity of genomic alterations to these tyrosine kinase inhibitor (TKIs). Patients who are CD20+ also receive rituximab IV on day 1 or day 5. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and every 6 months for 3 years.
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorRyan Daniel Cassaday
