Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies (NCT01724528) | Clinical Trial Compass
CompletedPhase 3
Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies
346 participantsStarted 2012-10
Plain-language 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
Who can participate
Age range18 Years
SexALL
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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