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

Completed · Phase 3

Conditions studied: Tumor Lysis Syndrome, Cancer, Hyperuricemia

In brief

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.

Key facts

Study ID

NCT00230178

Run by

Sanofi

People needed

280

Starts

2004-04-01

Expected to finish

2007-12-01

Last updated by the study team

2010-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Alta Bates Comprehensive Cancer Center — Berkeley, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• University of Florida Health Science Center at Jacksonville — Jacksonville, Florida, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• New York Methodist Hospital — Brooklyn, New York, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• New York Medical College — Valhalla, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Oregon Health and Sciences University — Portland, Oregon, United States
• University of Pennsylvania Health Systems — Philadelphia, Pennsylvania, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Mary Babb Randolph Cancer Center — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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