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Uric Acid

Allopurinol

Rasburicase

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Rasburicase alone given as a single agent for 5 days

Rasburicase alone given as a single agent from Day 1 through Day 3, followed by oral allopurinol given from Day 3 through Day 5 (Day 3 is an overlap)

Oral allopurinol alone given as a single agent for 5 days

Rasburicase (SR29142)

International Clinical Development

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.

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

Evaluation of Single Agent Rasburicase for 5 Days Versus Sequential Treatment With Rasburicase From Day 1 Through 3 Followed by Oral Allopurinol From Day 3 Through 5 (Overlap on Day 3) Versus Single Agent Oral Allopurinol for 5 Days in the Management of Plasma Uric Acid in Adult Patients With Leukemia, Lymphoma, and Solid Tumor Malignancies at Risk for Hyperuricemia and Tumor Lysis Syndrome

Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 \<7.5 mg/dl.

Area under the curve concentration versus time curve extrapolated to infinity (AUC) of plasma uric acid values

Time from the first dose of study drug to the time at which plasma uric acid concentrations were determined \<=7.5 mg/dl, measured -4, 4, 24, 48, 72, 96, 120, and 144 hours after infusion.

Sanofi

International Clinical Development, Clinical Study Director

Reported events are treatment emergent adverse events within the time frame mentioned above.

Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days

Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)

Rasburicase + Allopurinol

Allopurinol (300 mg/day) given alone as a single agent for 5 days

Total

<65 years

>=65 years

Age, Customized

Sex: Female, Male

Responder

Non-Responder

Plasma Uric Acid Responder

The analysis was performed on the modified ITT-population with an evaluation of plasma uric acid AUC.

Plasma Uric Acid

The analysis was performed on a subgroup of patients from the mITT-population with hyperuricemia immediately prior to the first dose of study drug.

Spots Global Cancer Trial Database for tumor lysis syndrome (cancer patients only)