Phase 3
Completed N=280
Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
Tumor Lysis Syndrome · Cancer · Hyperuricemia
Source: ClinicalTrials.gov NCT00230178 ↗
Enrolled (actual)
280
Serious AEs
35.3%
Results posted
Dec 2009
Primary outcomePrimary: Plasma Uric Acid Responder — 80; 72; 60; 12 Participants — p=0.0009
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 compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Uric Acid Responder |
80; 72; 60; 12; 20; 31 | 0.0009 sig |
| SECONDARY Plasma Uric Acid |
77.25; 108.05; 646.22 | <0.0001 sig |
| SECONDARY Time to Uric Acid Control |
4.1; 4.1; 27.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00230178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.