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Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies

NCT01724528 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 346

Last updated 2014-11-03

Study results available
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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

Interventions

DRUG

Febuxostat

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

DRUG

Allopurinol

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)

Sponsors & Collaborators

  • Menarini Group

    lead INDUSTRY

Principal Investigators

  • Michele Spina, MD · Centro Riferimento Oncologico (CRO) National Cancer Institute-Aviano-Italy

  • Angela Capriati, MD, PhD · Menarini Ricerche S.p.A. - Florence-Italy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-10-31
Completion
2013-10-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01724528 on ClinicalTrials.gov