Clinical trial · Interventional
Safety and Efficacy of TULY (Rasburicase) in Prevention and Treatment of Malignancy-associated Hyperuricemia
Efficacy and Safety of TULY in Prevention and Treatment of Malignancy-associated Hyperuricemia
- 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)
This study is a prospective, open-label, multicentre study. Hundred eligible patients with stage III or IV non-Hodgkin lymphoma (NHL) or acute lymphoblastic leukemia (ALL) with a peripheral white blood cell (WBC) count of \> 25,000/µL or any leukemia or lymphoma with plasma uric acid level of at least 8 mg/dL will be treated with rasburicase 0.20 mg/kg body weight intravenously for 4 days. The primary endpoints viz., the percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy, plasma uric acid AUC 0-96 hr and incidence of adverse events will be assessed during 11 days study period.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TULY | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tuly, uric acid lowering drug
- description
- TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days
- interventionNames
- Drug: TULY
Primary outcomes (1)
- measure
- Percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy
- timeFrame
- At the end of 4 hrs after initiation of uric acid lowering therapy; during 96 hrs of uric acid lowering therapy; Adverse events during the entire study period
Secondary outcomes (2)
- measure
- Plasma uric acid AUC 0-96 hr
- timeFrame
- At the end of 4 hrs after initiation of uric acid lowering therapy; during 96 hrs of uric acid lowering therapy; Adverse events during the entire study period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients of both genders aged between 1 to 75 years; 2. Patients with stage III or IV non-Hodgkin lymphoma (NHL) or acute lymphoblastic leukemia (ALL) with a peripheral WBC count of \>25,000/µL or any leukemia or lymphoma with plasma uric acid level of at least 8 mg/dL; 3. Eastern Cooperative Oncology Group (ECOG) performance scale of ≤3; 4. Patients scheduled to receive chemotherapy. Exclusion Criteria: 1. Patients with allergy or asthma, or hypersensitivity to urate oxidase, or hemolytic reactions; 2. Pregnant and lactating; 3. Patients with glucose-6-phosphate dehydrogenase deficiency; 4. Exposure to rasburicase or allopurinol within 7 days; 5. History of psychiatric or co-morbid unstable medical conditions
References
Publications (0)
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