Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menarini Group
• Treatments: Allopurinol; Febuxostat

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