This phase II trial studies how well etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride with asparaginase work in treating patients with acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, 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. Asparaginase breaks down the amino acid asparagine and may block the growth of tumor cells that need asparagine to grow. Giving combination chemotherapy with asparaginase may work better in treating patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.
PRIMARY OBJECTIVES: I. To determine the efficacy of dose-adjusted etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride plus asparaginase (DA-EPOCH-A) in adults with acute lymphoblastic leukemia/lymphoma (ALL). SECONDARY OBJECTIVES: I. To evaluate the safety and feasibility of this regimen. OUTLINE: Patients receive etoposide, doxorubicin hydrochloride, and vincristine sulfate intravenously (IV) continuously over days 1-4, cyclophosphamide IV over 1 hour on day 5, and prednisone orally (PO) twice daily (BID) on days 1-5. Patients also receive asparaginase intramuscularly (IM) or IV over 1-2 hours every 2-3 days, beginning day 7 of each course. Patients who are cluster of differentiation (CD)20 positive and Philadelphia chromosome negative also receive rituximab IV on day 1 or 5. Patients who are Philadelphia chromosome positive also receive imatinib mesylate PO on days 1-14. Treatment repeats every 21 days for up to 8 courses 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 then every 6 months for 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Given IM or IV
Given IV
Given IV
Given IV
Given PO
Correlative studies
Given PO
Given IV
Given IV
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Complete minimal residual disease response rate
A Simon two-stage optimum design will be used to define success of this treatment in the two subgroups of patients.
Time frame: Up to 5 years
Overall response rate (complete response + partial response)
A Simon two-stage optimum design will be used to define success of this treatment in the two subgroups of patients.
Time frame: Up to 5 years
Overall survival
A Simon two-stage optimum design will be used to define success of this treatment in the two subgroups of patients.
Time frame: From time of initiation of study therapy to up to 5 years
Progression-free survival
A Simon two-stage optimum design will be used to define success of this treatment in the two subgroups of patients.
Time frame: From time of initiation of study therapy to up to 5 years
Incidence of adverse events, graded using the National Cancer Institute Common Terminology Criteria for Adverse Events
Time frame: Up to 30 days post-treatment, or until patient receives an alternative anti-cancer therapy, whichever date comes first
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