Clinical trial · Interventional
Evaluate the Efficacy and Safety of Rasburicase (Fasturtec®) in the Prevention and Treatment of Hyperuricemia in Pediatric Patients With Non-Hodgkin's Lymphoma and Acute Leukemia
An Open-label, Single-arm, Multi-center Study to Evaluate the Efficacy and Safety of Rasburicase (Fasturtec) in the Prevention and Treatment of Hyperuricemia in Pediatric Patients With Non-Hodgkin¿s Lymphoma and Acute Leukemia
NCT04349306CI-TRIAL-00058011RAISEcompletedPhase 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)
Primary Objective: To evaluate safety of rasburicase in pediatric patients with NHL and AL Secondary Objective: To assess efficacy of rasburicase for prevention and treatment of hyperuricemia
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RASBURICASE SR29142 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- rasburicase
- description
- rasburicase 0.20 mg/kg/day by intravenous (IV) over 30 minutes for 1 to 5 days according to the level of plasma uric acid or Investigator's clinical judgement
- interventionNames
- Drug: RASBURICASE SR29142
Primary outcomes (1)
- measure
- Incidence of AEs and SAEs
- timeFrame
- Day 1 to Day 7
- description
- Incidence of AE or SAE will be summarized as the number and percentage of subjects who experienced any AE or SAE during the treatment period.
Secondary outcomes (3)
- measure
- Number of responders after completion of rasburicase treatment under chemotherapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion criteria : * Patient or parent/legal guardian is willing and able to provide signed informed consent, and if required, the patient is willing to provide assent. * Children or adolescent aged 2 to 18 years old (inclusive) at time of signing of informed consent. * At screening, the patient is expected to have a minimum life expectancy of 45 days and has a performance status (PS) no greater than 3 on the Eastern Cooperative Oncology Group (ECOG) scale, or a PS no less than 30 on the Lansky score as per the Investigator's preference (see Appendix D for ECOG and Lansky scale). * Newly diagnosed NHL or AL who is at the initiation of or during the first cycle of chemotherapy,baseline blood uric acid greater than 8 mg/dL (473 mol/L) at screening. * If newly diagnosed NHL patient with blood uric acid no greater than 8 mg/dL at screening, the patient must be diagnosed with Stage III or IV non-Hodgkin's lymphoma with high tumor burden which will be high risk of TLS defined, with one or more of following below: A. Burkitt lymphoma/leukemia or -lymphoblastic lymphoma, and/or B. Has at least one of lymph node or tumor, the diameter \>5 cm, and/or C. Lactate dehydrogenase (LDH) no less than 2 times the upper limit of normal (ULN). * If newly diagnosed AL patient is with blood uric acid no greater than 8 mg/dL at the screening but with a high risk of TLS defined with one of the following below criteria: A. White blood cell (WBC) no less than 100.0 10-9/L, or B. WBC \< 100.0 10-9/L with LDH no less than 2 ULN. * The patient will receive the chemotherapy, and will be confined in hospital for at least 14 days after first dose of rasburicase. Exclusion criteria: * Acute promyelocytic leukemia * Patient who has been treated or planned to receive allopurinol within 72 hours of rasburicase administration. * Patients with abnormal liver or renal function: alanine aminotransferase (ALT) \>5 ULN, total bilirubin \>3 ULN, serum creatinine \>3 ULN. * Documented history of hereditary allergy or asthma. * Patients with known deficiency of glucose-6-phosphate dehydrogenase (G6PD), or a history of hemolytic disease or methemoglobinemia. * Patients with severe infection or active bleeding. * Previous therapy with urate oxidase. * Hypersensitive reaction against rasburicase or any of the other ingredients of the study drug. * Patient is not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures. * Pregnant or breastfeeding woman. * Woman of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy (see contraceptive guidance in Appendix A). * Male participant with a female partner of childbearing potential not protected by highly-effective method(s) of birth control 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
No reference posted for this study.