Recurrent Adult Acute Lymphoblastic Leukemia Clinical Trial
Official title:
A Phase II Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin Plus Asparaginase (DA-EPOCH-A) for Adults With Acute Lymphoblastic Leukemia/Lymphoma
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.
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