Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome

After signing the informed consent and having met the inclusion criteria, patients will be randomized to 1 of the 3 arms and treated for a total duration of 5 days. Patients in all arms will receive chemotherapy beginning 4-24 hours after the first dose of rasburicase or allopurinol.

Inclusion criteria

• Meets high risk or at potential risk for tumor lysis syndrome (TLS):

A patient is at high risk for TLS if he/she presents with:

• Hyperuricemia of malignancy (plasma uric acid > 7.5 mg/dL);
• A diagnosis of very aggressive lymphoma/leukemia based on the Revised European-American Lymphoma (REAL) classification of lymphoma/leukemia;
• Acute myeloid leukemia (AML);
• Chronic myeloid leukemia (CML) in blast crisis; or
• High grade myelodysplastic syndrome (refractory anemia with excess blast, chronic myelomonocytic leukemia, and refractory anemia with excess blast in transformation) only if they have > 10% bone marrow blast involvement and are given aggressive treatment similar to AML.

A patient is at potential risk for TLS if he/she presents with:

• A diagnosis of aggressive lymphoma/leukemia based on the REAL classification of lymphoma/leukemia plus 1 or more of the following criteria:

• Lactate dehydrogenase (LDH) >= 2 x upper limit of normal (ULN) (IU/L)
• Stage III-IV disease
• Stage I-II disease with at least 1 lymph node/tumor > 5 cm in diameter

In addition to the above-mentioned eligibility criteria, the patients should have the following criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-3
• Age >= 18 years
• Life expectancy > 3 months
• Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (for both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG).
• Signed written informed consent