Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
This is a randomized, multi-center, open-label, parallel group study with three arms:

 -  Rasburicase alone

 -  Rasburicase followed by Allopurinol

 -  Allopurinol alone

 The primary objective is to compare the adequacy of control of plasma uric acid concentration
 and the safety profile among the three arms.
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:

 1. 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:

 2. Eastern Cooperative Oncology Group (ECOG) performance status 0-3

 3. Age >= 18 years

 4. Life expectancy > 3 months

 5. 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).

 6. Signed written informed consent