Pharmacokinetic Evaluation of Rasburicase in Patients With Leukemia and/or Lymphoma at High Risk … (NCT00360438) | Clinical Trial Compass
CompletedPhase 1/2
Pharmacokinetic Evaluation of Rasburicase in Patients With Leukemia and/or Lymphoma at High Risk of TLS
United States18 participantsStarted 2006-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age \>/= 18
✓. Risk of TLS: A. High risk: hyperuricemia of malignancy; diagnosis of aggressive lymphoma/leukemia based on Revised European-American Lymphoma (REAL) classification; acute myeloid leukemia in blast crisis; high grade myelodysplastic syndrome only if they have \>10% bone marrow blast involvement and given aggressive treatment similar to AML; OR B. Potential risk: diagnosis of aggressive lymphoma/leukemia based on (REAL) classification. Plus one or more of the following criteria: LDH \>/=2 x ULN; Stage III-IV disease; Stage I-II disease with at least 1 lymph node/tumor \>5cm in diameter.
✓. ECOG performance status 0-3
✓. Life expectancy \>3 months
✓. Negative pregnancy test (females of child bearing potential) within \</=2 weeks of rasburicase dose and use of efficient contraceptive method (both males and females). Pregnancy test may be performed on serum (HCG) or urine (HCG)
✓. Signed written informed consent (approved by the Institutional Review Board/Ethics Committee) obtained prior to study entry
Exclusion criteria
✕. Patient receiving any investigational drug for hyperuricemia within 30 days of planned first treatment with rasburicase
What they're measuring
1
Effectiveness of rasburicase in treatment of patients with leukemia and/or lymphoma who are at high or potential risk for TLS.