Status:
COMPLETED
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
Lead Sponsor:
Sanofi
Conditions:
Lymphoma
Eligibility:
All Genders
2-18 years
Phase:
PHASE4
Brief Summary
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
Detailed Description
Study duration per participants is approximatively 14 days including a 5-day treatment period.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04349306
Start Date
May 14 2020
End Date
March 12 2021
Last Update
April 25 2022
Active Locations (1)
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1
investigational site CHINA
China, China