TerminatedPhase 1/2

Febuxostat for Tumor Lysis Syndrome Prevention in Hematological Malignancies of Paediatric Patients and Adults

Stopped: The study was stopped as per EMA waiver granted on 20July2018.

Bulgaria, Hungary, Italy30 participantsStarted 2017-02-27

Plain-language summary

The purpose of this study is to compare the exposure of febuxostat in pediatric patients (≥6\<18 years of age) and in adults suffering from hematological malignancies at intermediate to high risk of TLS and to compare the effect in terms of serum uric acid levels.

Who can participate

Age range

6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: male and female children of 6 to less than 12 years of age, adolescents of 12 to less than 18 years of age and adults from 18 years: * scheduled for first cytotoxic chemotherapy cycle because of hematologic malignancies * and at intermediate or high risk of TLS * and with no access to rasburicase Exclusion Criteria: * patients with contraindications as per febuxostat summary of product characteristics * patients with severe renal insufficiency * patients with severe hepatic insufficiency * patients with diagnosis of Laboratory TLS (LTLS) or Clinical TLS (CTLS)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pharmacokinetic (PK) Parameter: Apparent Clearance (CL/F)

Timeframe: 7 days

PK Parameter: Apparent Volume of Distribution (Vd/F)

Timeframe: 7 days

PK Parameter: Absorption Rate Constant (Ka)

Timeframe: 7 days

PK Parameter: Area Under Curve (AUC)

Timeframe: 7 days

PK Parameter: Maximum Plasma Concentration (Cmax)

Timeframe: 7 days

PK Parameter: Tmax

Timeframe: 7 days

Trial details

NCT IDNCT03605212

SponsorMenarini Group

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-07-25

Results submitted2021-01-27

View on ClinicalTrials.gov More Tumor Lysis Syndrome trials

Who can participate

Age range

6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Pharmacokinetic (PK) Parameter: Apparent Clearance (CL/F)

Timeframe: 7 days

PK Parameter: Apparent Volume of Distribution (Vd/F)

Timeframe: 7 days

PK Parameter: Absorption Rate Constant (Ka)

Timeframe: 7 days

PK Parameter: Area Under Curve (AUC)

Timeframe: 7 days

PK Parameter: Maximum Plasma Concentration (Cmax)

Timeframe: 7 days

PK Parameter: Tmax

Timeframe: 7 days