Status:
COMPLETED
Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
Lead Sponsor:
Sanofi
Conditions:
Tumor Lysis Syndrome
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized, multi-center, open-label, parallel group study with three arms: * Rasburicase alone * Rasburicase followed by Allopurinol * Allopurinol alone The primary objective is to compar...
Detailed Description
After signing the informed consent and having met the inclusion criteria, patients will be randomized to 1 of the 3 arms and treated for a total duration of 5 days. Patients in all arms will receive c...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Meets high risk or at potential risk for tumor lysis syndrome (TLS):
- 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:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- Age \>= 18 years
- Life expectancy \> 3 months
- 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).
- Signed written informed consent
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00230178
Start Date
April 1 2004
End Date
December 1 2007
Last Update
January 12 2010
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
2
UCLA Medical Center
Los Angeles, California, United States, 90095
3
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
4
University of Florida Health Science Center at Jacksonville
Jacksonville, Florida, United States, 32209