Conditions: Tumor Lysis Syndrome Cancer Hyperuricemia
Keywords: Hyperuricemia Tumor lysis syndrome Leukemia Lymphoma Myelodysplastic Syndromes Solid tumor cancers Solid Tumor cancers with hyperuricemia Hyperuricemia (cancer patients only) Tumor lysis syndrome (cancer patients only)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 280
Healthy volunteers: no

Brief 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.

Detailed 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.

Arms:
arm 1: Rasburicase alone given as a single agent for 5 days arm 2: 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) arm 3: Oral allopurinol alone given as a single agent for 5 days

Interventions: intervention 1: Rasburicase (SR29142) intervention 2: Allopurinol
Intervention descriptions: intervention 1: 30-min IV infusion intervention 2: Oral administration

Protocol document: