Clinical trial · Interventional
Febuxostat for Tumor Lysis Syndrome Prevention in Hematological Malignancies of Paediatric Patients and Adults
Open Label, Multi-centre, Parallel Group Study to Compare the Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of Febuxostat Between Pediatric Patients (≥6<18 Years of Age) and Adults
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was stopped as per EMA waiver granted on 20July2018.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumor Lysis Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Febuxostat | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Febuxostat film-coated tablets 2x20 mg/QD for 7-9 days
- interventionNames
- Drug: Febuxostat
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Febuxostat film-coated tablets 3x20 mg/QD for 7-9 days
- interventionNames
- Drug: Febuxostat
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
- Febuxostat film-coated tablets 1x80 mg/QD for 7-9 days (Adenuric® 80 mg)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available