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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 12, 2021

Detailed Description

Study duration per participants is approximatively 14 days including a 5-day treatment period.

Interventions

  • Drug: RASBURICASE SR29142
    • Pharmaceutical form:solution for infusion Route of administration: intravenous

Arms, Groups and Cohorts

  • Experimental: rasburicase
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of AEs and SAEs
    • Time Frame: Day 1 to Day 7
    • 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 Measures

  • Number of responders after completion of rasburicase treatment under chemotherapy
    • Time Frame: Day 1 to Day 7
    • Response will be defined as achievement of normal uric acid levels (≤ 8.0 mg/dL) in those patients whose uric acid levels are >8.0 mg/dL.
  • Proportion of patients who can maintain the normal uric acid levels throughout the study
    • Time Frame: Day 1 to Day 7
    • In those patients whose baseline plasma uric acid levels are ≤ 8 mg/dL but with a high risk of TLS.
  • Percentage of the maximum decreasing degree of plasma uric acid level from baseline
    • Time Frame: Day 1 to Day 7

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Sciences & Operations, Study Director, Sanofi

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