Phase 2
Completed N=80
Rasburicase in Patients at Risk for Tumor Lysis Syndrome
Tumor Lysis Syndrome
Source: ClinicalTrials.gov NCT00628628 ↗
Enrolled (actual)
80
Serious AEs
2.5%
Results posted
Aug 2013
Primary outcomePrimary: Number of Participants With Plasma Uric Acid (UA) Response — 39; 34 participants
Summary
Primary Objectives:
To determine the efficacy of rasburicase administered as a single dose followed by as needed dosing (investigational arm) as compared to fixed dosing for 5 days (standard treatment arm) in the treatment of patients at high risk or potential risk for tumor lysis syndrome.
Secondary Objectives:
1. To evaluate the plasma uric acid area under the curve (AUC) from baseline through 7 days
2. To evaluate the incidence of renal insufficiency and electrolyte abnormalities.
3. To determine the safety and immunogenicity of rasburicase.
4. To evaluate the cost-effectiveness of the experimental treatment (investigational arm).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Plasma Uric Acid (UA) Response |
39; 34 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with hematological malignancies (leukemia/lymphoma) at high risk or potential risk for tumor lysis syndrome. High risk: hyperuricemia of malignancy (Uric acid levels >7.5); diagnosis of very aggressive lymphoma/leukemia based on Revised European-American Lymphoma (REAL) classification; acute myeloid leukemia, chronic myelocytic leukemia (CML) in blast crisis; high grade myelodysplastic syndrome only if they have >10% bone marrow blast involvement and given aggressive treatment similar to acute myeloid leukemia (AML) (continued on #2)
- (continued from # 1) Potential risk: diagnosis of aggressive lymphoma/leukemia based on (REAL) classification. Plus one or more of the following criteria: lactate dehydrogenase (LDH) >/= 2 x upper limit of normal (ULN); Stage III-IV disease; Stage I-II disease with at least 1 lymph node/tumor >5cm in diameter.
- ECOG performance status 0-3
- Life expectancy >3 months
- 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)
- Signed written informed consent (approved by the Institutional Review Board/Ethics Committee) obtained prior to study entry
Exclusion Criteria
- Patient receiving any investigational drug for hyperuricemia within 30 days of planned first treatment with rasburicase
- Pregnancy or lactation
- Known history of significant allergy problem or documented history of asthma or asthmatic bronchitis
- Known history of glucose-6-phosphate dehydrogenase deficiency
- Known history of hemolysis and methemoglobinemia
- Previous therapy with urate oxidase
- Other conditions unsuitable for participation in the trial in the Investigator's opinion
- Unwillingness to comply with the requirements of the protocol
- Use of allopurinol within 72 hours of the study entry
Data sourced from ClinicalTrials.gov (NCT00628628). 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.