Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies

NCT01724528 | Completed Phase 3 Results

• 2 other identifiers: FLO-012012-000776-42
• Study Type: interventional
• Target: 346
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Tumor Lysis Syndrome

Keywords

Febuxostat, Tumor lysis syndrome, leukemia, lymphoma

Outcome Measures

Primary Outcomes (2)

• Serum Uric Acid (sUA) Level Control

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

  8 days

• Preservation of Renal Function

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

  8 days

Secondary Outcomes (3)

• Treatment Responder Rate

  6 days

• Assessment of Laboratory Tumor Lysis Syndrome (LTLS)

  6 days

• Assessment of Clinical Tumor Lysis Syndrome (CTLS)

  6 days

Other Outcomes (1)

• Treatment Emergent Signs or Symptoms (TESS)

  14 ± 2 days

Study Arms (2)

Febuxostat

EXPERIMENTAL

Febuxostat for 7-9 days

Drug: Febuxostat

Allopurinol

ACTIVE COMPARATOR

Allopurinol for 7-9 days

Drug: Allopurinol

Interventions

Febuxostat DRUG

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

Also known as: Adenuric

Febuxostat

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)

Also known as: Zyloric

Allopurinol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Menarini Group: lead

Related Publications (1)

• Spina 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 DERIVED

MeSH Terms

Conditions

Tumor Lysis Syndrome; Leukemia; Lymphoma

Interventions

Febuxostat; Allopurinol

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Angela Capriati, Corporate Clinical Research Director
• Organization: Menarini Ricerche S.p.A.

acapriati@menarini-ricerche.it

+39 055 5680

Study Officials

• Michele Spina, MD

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

  PRINCIPAL INVESTIGATOR

• Angela Capriati, MD, PhD

  Menarini Ricerche S.p.A. - Florence-Italy

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: November 9, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 3, 2014
• Results First Posted: November 3, 2014

Record last verified: 2014-10