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

• Status: Terminated
• Trial end date: 2018-07-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menarini Group
• Treatments: Febuxostat

Criteria

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)