Lymphoma
Conditions
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.
Interventions
DRUGRASBURICASE SR29142
Pharmaceutical form:solution for infusion Route of administration: intravenous
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AEs and SAEs | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of responders after completion of rasburicase treatment under chemotherapy | 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 | 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 | Day 1 to Day 7 | — |
Countries
China
Outcome results
None listed