Pharmacokinetic Evaluation of Rasburicase in Patients With Leukemia and/or Lymphoma at High Risk of TLS
Status:
Completed
Trial end date:
2007-04-01
Target enrollment:
Participant gender:
Summary
Primary
1. To determine the pharmacokinetic (PK) parameters of rasburicase in adult patients with
leukemia and/or lymphoma at high risk or potential risk of tumor lysis syndrome (TLS)
Secondary
1. To evaluate plasma uric acid AUC from baseline (within 4 hours prior to first
rasburicase treatment) through 48 hours after the last per-protocol planned
administration of rasburicase treatment;
2. To evaluate the safety of rasburicase in adult patients with leukemia and/or lymphoma.
3. To evaluate incidence, duration, and type of immune responses (IgG, IgE, and
neutralizing antibody) to rasburicase.