Pharmacokinetic Evaluation of Rasburicase in Patients With Leukemia and/or Lymphoma at High Risk of TLS
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|ClinicalTrials.gov Identifier: NCT00360438|
Recruitment Status : Completed
First Posted : August 4, 2006
Last Update Posted : August 1, 2012
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)
- 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;
- To evaluate the safety of rasburicase in adult patients with leukemia and/or lymphoma.
- To evaluate incidence, duration, and type of immune responses (IgG, IgE, and neutralizing antibody) to rasburicase.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma Tumor Lysis Syndrome||Drug: Rasburicase||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetic Evaluation of Rasburicase Dosed for 5 Consecutive Days as Uricolytic Therapy in Adult Patients With Leukemia and/or Lymphoma at High or Potential Risk of Tumor Lysis Syndrome (TLS)|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
0.15mg/kg intravenously over 30 minutes once per day for 5 consecutive days.
Other Name: Elitek
- Effectiveness of rasburicase in treatment of patients with leukemia and/or lymphoma who are at high or potential risk for TLS. [ Time Frame: 4 Years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00360438
|United States, Texas|
|The University of Texas M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Saroj Vadhan-Raj, M.D.||M.D. Anderson Cancer Center|