Phase 3
Completed N=346
Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies
Tumor Lysis Syndrome
Source: ClinicalTrials.gov NCT01724528 ↗
Enrolled (actual)
346
Serious AEs
7.8%
Results posted
Nov 2014
Primary outcomePrimary: Serum Uric Acid (sUA) Level Control — 514.0; 708.0 mg x hour/dL — p=<0.0001
Summary
The purpose of this study is to determine whether febuxostat is superior to allopurinol in the prevention of tumor lysis syndrome (TLS) in patients with hematological malignancies at intermediate or high risk of TLS (according to Cairo-Bishop classification) who undergo chemotherapy
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Uric Acid (sUA) Level Control |
514.0; 708.0 | <0.0001 sig |
| PRIMARY Preservation of Renal Function |
-0.83; -4.92 | 0.0903 |
| SECONDARY Treatment Responder Rate |
1.7; 4.0 | 0.1993 |
| SECONDARY Assessment of Laboratory Tumor Lysis Syndrome (LTLS) |
8.1; 9.2 | 0.8488 |
| SECONDARY Assessment of Clinical Tumor Lysis Syndrome (CTLS) |
1.7; 1.2 | 1.0000 |
Eligibility Criteria
Inclusion Criteria
- Patients scheduled for first cytotoxic chemotherapy cycle, regardless of the line of treatment, because of hematologic malignancies at intermediate or high risk of TLS (according to the TLS risk stratification, Cairo M et al, British Journal of Haematology, 2010)candidate to Allopurinol treatment or have no access to Rasburicase
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3
- Life expectancy > 1 month
Exclusion Criteria
- Patients known to be hypersensitive to Febuxostat or Allopurinol or to any of the components of the formulations
- Patients with sUA levels ≥ 10 mg/dL at randomization
- Patients receiving Febuxostat, Allopurinol or any other urate lowering therapy (e.g. Rasburicase, probenecid) within 30 days prior to randomization
- Patients with severe renal and/or hepatic insufficiency
- Patients with diagnosis of LTLS or CTLS at randomization
Data sourced from ClinicalTrials.gov (NCT01724528). 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.