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

Menarini

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Tumor Lysis Syndrome

Treatments: Drug: Febuxostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT03605212

2016-001445-61 (EudraCT Number)

FLO-02

Details and patient eligibility

About

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.

Full description

In the FLORET study it is planned to enroll 3 groups of patients in order to receive oral administration (film-coated tablets) of two different dose levels of febuxostat: children (from 6 to less than 12 years of age) will receive two different dose levels respectively; adolescents (from 12 to less than 18 years of age) will receive 80 and 120 mg/day respectively and adults (equal or major than 18 years of age) will receive 120 mg/day. The two dose levels for children and adolescents groups were to be sequentially administered, whereas the groups that will receive the first dose levels will simultaneously start the treatment at the study beginning. The individual treatment duration will be of 7 to 9 days, according to chemotherapy duration, as per Investigator's judgement.

Enrollment: 30 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 5 patient groups

Cohort 1

Experimental group

Description:

Febuxostat film-coated tablets 2x20 mg/QD for 7-9 days

Treatment:

Drug: Febuxostat

Cohort 2

Experimental group

Description:

Febuxostat film-coated tablets 3x20 mg/QD for 7-9 days

Treatment:

Drug: Febuxostat

Cohort 3

Experimental group

Description:

Febuxostat film-coated tablets 1x80 mg/QD for 7-9 days (Adenuric® 80 mg)

Treatment:

Drug: Febuxostat

Cohort 4

Experimental group

Description:

Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)

Treatment:

Drug: Febuxostat

Adults

Active Comparator group

Description:

Febuxostat film-coated tablets 120 mg/QD for 7-9 days (Adenuric® 120 mg)

Treatment:

Drug: Febuxostat