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Completed

NCT Number: NCT01724528

Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies

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

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Key information

Conditions

Tumor Lysis Syndrome Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Febuxostat

Drug

Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)

Other names: Adenuric

Allopurinol

Drug

Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)

Other names: Zyloric

Primary outcomes

  1. Serum Uric Acid (sUA) Level Control

    Time frame: 8 days

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

  2. Preservation of Renal Function

    Time frame: 8 days

    Change in serum creatinine level from baseline (Day 1) to the evaluation visit (Day 8)

Secondary outcomes

  1. Treatment Responder Rate

    Time frame: 6 days

    Assessment of treatment responder rate, where treatment response is defined as the maintenance of sUA ≤ 7.5 mg/dL from Day 3 to Day 8

  2. Assessment of Laboratory Tumor Lysis Syndrome (LTLS)

    Time frame: 6 days

    Assessment of LTLS, from Day 3 to Day 8. According to Cairo-Bishop definition LTLS is defined by the presence of 2 or more laboratory abnormalities including: a 25% increase or levels above normal for serum uric acid, potassium, and phosphate or a 25% decrease or levels below normal for calcium.

  3. Assessment of Clinical Tumor Lysis Syndrome (CTLS)

    Time frame: 6 days

    Assessment of CTLS, from Day 3 to Day 8. According to Cairo-Bishop definition, CTLS is defined by the presence of LTLS in addition to 1 or more of the following significant clinical complications: renal insufficiency, cardiac arrhythmias, sudden death and seizures. The grade of CTLS is defined by the maximal grade of the clinical manifestation

Other outcomes

  1. Treatment Emergent Signs or Symptoms (TESS)

    Time frame: 14 ± 2 days

    Incidence, severity, seriousness and treatment-causality of TESS

Sponsors and collaborators

Lead sponsor

Menarini Group

Industry

Registry information

Official study title

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

Acronym: FLORENCE

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 9, 2012
Registry last updated
Nov 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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