Status:
COMPLETED
Study of Rasburicase as Treatment or Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Patients With Relapsed or Refractory Lymphoma, Leukemia, or Solid Tumor Malignancy
Lead Sponsor:
Sanofi
Conditions:
Tumors
Hyperuricemia
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
This is an open-label, multi-center study with 2 arms. The primary objective is to assess the response to treatment with rasburicase in 2 populations of adult and pediatric patients with lymphoma/leuk...
Detailed Description
This is a multi-center, 2 arm, open-label study; * Arm A: Patients previously treated with a uricolytic agent; * Arm B: Patients not previously treated with a uricolytic agent. Patients receive rasb...
Eligibility Criteria
Inclusion
- Meets one of the following risk criteria 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 a 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, refractory anemia with excess blast in transformation, or chronic myelomonocytic leukemia) only if they have \> 10% bone marrow blast and are given aggressive treatment similar to AML
- A patient is at potential risk for TLS if he/she presents with:
- A diagnosis of an 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 1 lymph node/tumor \> 5 cm in diameter
- Patients previously treated with a uricolytic agent or not at their first relapse or refractory disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3. ECOG equivalent derived from Karnofsky performance scale 100-30 or Lansky performance score 100-30 (patients \< or = 16 years of age) may also be used.
- Life expectancy \>3 months
- Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG).
- Signed written informed consent
Exclusion
- History of established diagnosis of asthma or severe life-threatening atopic allergy
- Hypersensitivity to uricases or any of the excipients
- Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or history of hemolysis indicative of G6PD deficiency
- Pregnant or lactating
- Concomitant treatment with any investigational drug
- Planned treatment with rituximab
- Receipt of rituximab within the 12 month period prior to study entry
- Unwilling or unable to comply with the requirements of the protocol
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00230217
Start Date
March 1 2004
End Date
July 1 2006
Last Update
March 30 2009
Active Locations (7)
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1
Alta Bates Comprehensive Cancer Center
Berkley, California, United States, 94704
2
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
3
University of Florida Health Science Center at Jacksonville
Jacksonville, Florida, United States, 32209
4
New York Medical College
Valhalla, New York, United States, 10595