Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
NCT ID: NCT00230178
Last Updated: 2010-01-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
280 participants
INTERVENTIONAL
2004-04-30
2007-12-31
Brief Summary
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* Rasburicase alone
* Rasburicase followed by Allopurinol
* Allopurinol alone
The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Arm A
Rasburicase alone given as a single agent for 5 days
Rasburicase (SR29142)
30-min IV infusion
Arm B
Rasburicase alone given as a single agent from Day 1 through Day 3, followed by oral allopurinol given from Day 3 through Day 5 (Day 3 is an overlap)
Rasburicase (SR29142)
30-min IV infusion
Allopurinol
Oral administration
Arm C
Oral allopurinol alone given as a single agent for 5 days
Allopurinol
Oral administration
Interventions
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Rasburicase (SR29142)
30-min IV infusion
Allopurinol
Oral administration
Eligibility Criteria
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Inclusion Criteria
A patient is at high risk for TLS if he/she presents with:
* Hyperuricemia of malignancy (plasma uric acid \> 7.5 mg/dL);
* A diagnosis of very aggressive lymphoma/leukemia based on the Revised European-American Lymphoma (REAL) classification of lymphoma/leukemia;
* Acute myeloid leukemia (AML);
* Chronic myeloid leukemia (CML) in blast crisis; or
* High grade myelodysplastic syndrome (refractory anemia with excess blast, chronic myelomonocytic leukemia, and refractory anemia with excess blast in transformation) only if they have \> 10% bone marrow blast involvement and are given aggressive treatment similar to AML.
A patient is at potential risk for TLS if he/she presents with:
* A diagnosis of aggressive lymphoma/leukemia based on the REAL classification of lymphoma/leukemia plus 1 or more of the following criteria:
* Lactate dehydrogenase (LDH) \>= 2 x upper limit of normal (ULN) (IU/L)
* Stage III-IV disease
* Stage I-II disease with at least 1 lymph node/tumor \> 5 cm in diameter
In addition to the above-mentioned eligibility criteria, the patients should have the following criteria:
2. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
3. Age \>= 18 years
4. Life expectancy \> 3 months
5. Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (for both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG).
6. Signed written informed consent
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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International Clinical Development
Role: STUDY_DIRECTOR
Sanofi
Locations
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Alta Bates Comprehensive Cancer Center
Berkeley, California, United States
UCLA Medical Center
Los Angeles, California, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
University of Florida Health Science Center at Jacksonville
Jacksonville, Florida, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
New York Methodist Hospital
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
New York Medical College
Valhalla, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Oregon Health and Sciences University
Portland, Oregon, United States
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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EFC4978
Identifier Type: -
Identifier Source: org_study_id
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