Lymphoma Clinical Trial
— RAISEOfficial title:
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
Verified date | April 2022 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 50 |
Est. completion date | March 12, 2021 |
Est. primary completion date | March 12, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | investigational site CHINA | China |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of AEs and SAEs | 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. | Day 1 to Day 7 | |
Secondary | Number of responders after completion of rasburicase treatment under chemotherapy | 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. | Day 1 to Day 7 | |
Secondary | Proportion of patients who can maintain the normal uric acid levels throughout the study | In those patients whose baseline plasma uric acid levels are = 8 mg/dL but with a high risk of TLS. | Day 1 to Day 7 | |
Secondary | Percentage of the maximum decreasing degree of plasma uric acid level from baseline | Day 1 to Day 7 |
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