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Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies: a Randomized, Double Blind, Phase III Study Versus Allopurinol

Phase 3
18 Years
Open (Enrolling)
Tumor Lysis Syndrome

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Trial Information

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

serum uric acid (sUA) level control

Outcome Description:

Area under the curve of sUA from baseline (Day 1) to the evaluation visit (Day 8)

Outcome Time Frame:

8 days

Safety Issue:


Principal Investigator

Michele Spina, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centro Riferimento Oncologico (CRO) National Cancer Institute-Aviano-Italy


Italy: The Italian Medicines Agency

Study ID:




Start Date:

October 2012

Completion Date:

September 2013

Related Keywords:

  • Tumor Lysis Syndrome
  • Febuxostat, Tumor lysis syndrome, leukemia, lymphoma
  • Tumor Lysis Syndrome
  • Hematologic Neoplasms