Clinical trial · Interventional
Rasburicase (Fasturtec) Registration Trial
A Multi-center, Randomized, Open-label, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Rasburicase (Fasturtec®) in the Prevention and Treatment of Hyperuricemia in Patients With Hematological Malignancies
- 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 patient enrollment is too difficult
Summary
Brief summary (as posted)
Primary: To compare the efficacy of Rasburicase versus allopurinol in controlling tumor lysis-related hyperuricemia in Chinese patients with leukemia or lymphoma. Secondary: To compare the efficacy and safety of Rasburicase versus allopurinol in Chinese patients stratified according to disease (leukemia or lymphoma ).
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 |
|---|---|---|---|
| Hyperuricemia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allopurinol | Drug | — | UNRESOLVED |
| Rasburicase | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- IV infusion at a dose level of 0.20mg/kg per day
- interventionNames
- Drug: Rasburicase
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- 100mg tablets, administered orally, according to standard medical practice
- interventionNames
- Drug: Allopurinol
Primary outcomes (5)
- measure
- Mean plasma uric acid AUC0-96
- timeFrame
- 0hour, 4hour, 12 hour and q12h thereafter
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * At high risk of malignancy and/or chemotherapy-induced hyperuricemia * Performance status less than 3 on ECOG scale or more than 30% KPS scale * Uric acid concentrations ≥ 8.0mg/dL * Suffering from non-Hodgkin's lymphoma Stage more than III, or acute lymphoblastic leukemia with peripheral with blood cell count more than 25,000/mm3, or any lymphoma or leukemia Exclusion Criteria: * Treatment with an investigational drug at any time during the 14-day study period (except for agents that are permitted by the Sponsor) * Pregnancy or lactation * Prior treatment with Uricozyme or Rasburicase * Scheduled to receive asparaginase either 24 hours after the first dose of rasburicase * Treatment with Allopurinol within the seven days preceding study Day 1 * History of significant atopic allergy problems or documented history of asthma * History of severe reaction to allopurinol * Known history of glucose-6-phosphate dehydrogenase deficiency. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
Data not yet available