Clinical trial · Interventional
Fasturtec TLS Treatment / Prophylysis
A Multicenter Open Label Study of the Efficacy and Safety of Rasburicase in the Treatment of Prophylysis for Tumor Lysis Syndrome
NCT00651911CI-TRIAL-00001387completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
An open-label study to determine the efficacy and safety of Rasburicase used for the prevention and treatment of tumor lysis syndrome
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 |
|---|---|---|---|
| urate oxidase | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the uricolytic response to rasburicase treatment
- timeFrame
- 5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection)
Secondary outcomes (1)
- measure
- To evaluate tumor lysis risk factors, treatments for tumor lysis syndrome and complications of treatment in patients treated prophylactically or therapeutically for tumor lysis syndrome
- timeFrame
- 5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Chemotherapy planned for at least 3 cycles * Undergoing cytoreductive chemotherapy for ALL, multiple myeloma or Burkitt's lymphoma stage III or IV * With a minimum life expectancy of 3 months * Uric acid \> 8 mg% * Negative pregnancy test \< or =to 2 weeks and efficient contraceptive method. * Negative HIV serology \< or =to 4 weeks * Patient or legal guardian has signed a written informed consent Exclusion Criteria: * Hypersensitivity to uricases or any of the excipients * Known history of G6PD deficiency. * Previous treatment with Rasburicase or Uricozyme® * Pregnancy or lactation * Treatment with any investigational drug within 30 days before planned first Rasburicase administration
References
Publications (0)
Data not yet available
No reference posted for this study.