Myelodysplastic Syndrome Clinical Trial
Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
Summary
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.
Full Description
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.
Eligibility Criteria
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
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There are 15 Locations for this study
Berkeley California, 94704, United States
Los Angeles California, 90095, United States
Denver Colorado, 80218, United States
Jacksonville Florida, 32209, United States
New Orleans Louisiana, 70121, United States
Boston Massachusetts, 02114, United States
Brooklyn New York, 11215, United States
Buffalo New York, 14263, United States
Rochester New York, 14642, United States
Valhalla New York, 10595, United States
Durham North Carolina, 27710, United States
Portland Oregon, 97201, United States
Philadelphia Pennsylvania, 19194, United States
Houston Texas, 77030, United States
Morgantown West Virginia, 26506, United States
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