Pharmacokinetic Evaluation of Rasburicase in Patients With Leukemia and/or Lymphoma at High Risk of TLS

Completed · Phase 1/Phase 2

Conditions studied: Leukemia, Lymphoma, Tumor Lysis Syndrome

In brief

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.

Key facts

Study ID

NCT00360438

Run by

M.D. Anderson Cancer Center

People needed

18

Starts

2006-07-01

Expected to finish

2007-04-01

Last updated by the study team

2012-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Patient receiving any investigational drug for hyperuricemia within 30 days of planned first treatment with rasburicase
• Pregnancy or lactation
• Known history of significant allergy problem or documented history of asthma or asthmatic bronchitis
• Known history of glucose-6-phosphate dehydrogenase deficiency
• Known history of hemolysis and methemoglobinemia
• Positive tests for HBs antigen, HCV antibodies, or HIV-1, 2 antibodies
• Hypersensitivity to uricases or any of the excipients
• Previous therapy with urate oxidase
• Other conditions unsuitable for participation in the trial in the Investigator's opinion
• Unwilling to comply with the requirements of the protocol

Where it is running

• The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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