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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
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:


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)


  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.

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Primary Completion Date : April 2007
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia Lymphoma
Drug Information available for: Rasburicase
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Rasburicase Drug: Rasburicase
0.15mg/kg intravenously over 30 minutes once per day for 5 consecutive days.
Other Name: Elitek

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Age >/= 18
  2. 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.
  3. ECOG performance status 0-3
  4. Life expectancy >3 months
  5. 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)
  6. Signed written informed consent (approved by the Institutional Review Board/Ethics Committee) obtained prior to study entry

Exclusion Criteria:

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

Information from the National Library of Medicine

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
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Saroj Vadhan-Raj, M.D. M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00360438     History of Changes
Other Study ID Numbers: 2006-0298
First Posted: August 4, 2006    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
Tumor Lysis Syndrome

Additional relevant MeSH terms:
Tumor Lysis Syndrome
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Gout Suppressants
Antirheumatic Agents