Clinical trial · Interventional
Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies
Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies: a Randomized, Double Blind, Phase III Study Versus Allopurinol
NCT01724528CI-TRIAL-00015973FLORENCEcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumor Lysis Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allopurinol | Drug | — | UNRESOLVED |
| Febuxostat | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Febuxostat
- description
- Febuxostat for 7-9 days
- interventionNames
- Drug: Febuxostat
- type
- ACTIVE_COMPARATOR
- label
- Allopurinol
- description
- Allopurinol for 7-9 days
- interventionNames
- Drug: Allopurinol
Primary outcomes (2)
- measure
- Serum Uric Acid (sUA) Level Control
- timeFrame
- 8 days
- description
- Area under the curve of sUA from baseline (Day 1) to the evaluation visit (Day 8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSpina M, Nagy Z, Ribera JM, Federico M, Aurer I, Jordan K, Borsaru G, Pristupa AS, Bosi A, Grosicki S, Glushko NL, Ristic D, Jakucs J, Montesinos P, Mayer J, Rego EM, Baldini S, Scartoni S, Capriati A, Maggi CA, Simonelli C; FLORENCE Study Group. FLORENCE: a randomized, double-blind, phase III pivotal study of febuxostat versus allopurinol for the prevention of tumor lysis syndrome (TLS) in patients with hematologic malignancies at intermediate to high TLS risk. Ann Oncol. 2015 Oct;26(10):2155-61. doi: 10.1093/annonc/mdv317. Epub 2015 Jul 27. PMID 26216382