Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies: a Randomized, Double Blind, Phase III Study Versus Allopurinol
This study is designed as a randomised, double-blind, active-controlled, parallel-group
study to be conducted in approximately 80 sites.
Approximately 340 male or female patients aged 18 or older suffering from hematologic
malignancies (de novo patients or relapsing patients) at intermediate to high risk of TLS
and scheduled for receiving the first cycle of cytotoxic chemotherapy, regardless of the
line of treatment, will be randomized in this study. Eligible patients (as per screening
visit) will be randomly allocated in a 1:1 ratio to Febuxostat or Allopurinol. The
double-blind treatment period starts two days prior to the planned beginning of chemotherapy
and continues for 7 to 9 consecutive days, according to Investigator judgment and on the
basis of the actual duration of chemotherapy regimen administered to the patient. Along the
study treatment, uric acid levels, creatinine levels, Laboratory TLS/Clinical TLS and
Adverse Events represent the major clinical findings to be monitored on a daily basis.
Overall the study encompasses 10 to 11 planned visits at site, including screening,
randomisation, on treatment and final follow up visits.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
serum uric acid (sUA) level control
Area under the curve of sUA from baseline (Day 1) to the evaluation visit (Day 8)
Michele Spina, MD
Centro Riferimento Oncologico (CRO) National Cancer Institute-Aviano-Italy
Italy: The Italian Medicines Agency