CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 346 enrolled
Drug / intervention
Febuxostat +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01724528
NCT01724528Phase 3Completed
CompareCT.gov

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

Menarini Group·interventional·Posted Nov 9, 2012·Updated Nov 3, 2014

In Brief

A Phase 3 clinical trial evaluating Febuxostat and Allopurinol for Tumor Lysis Syndrome. Completed, enrolled 346 participants.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTumor Lysis Syndrome
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 9, 2012
Enrollment StartOct 1, 2012
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.6 years ago

Interventions

Febuxostatdrug

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

Allopurinoldrug

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)