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 (RAISE)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Lymphoma

Treatments: Drug: RASBURICASE SR29142

Study type: Interventional

Funder types: Industry

Identifiers

NCT04349306

U1111-1233-0737 (Other Identifier)

RASBUL09107

Details and patient eligibility

About

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 description

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

Enrollment: 50 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

rasburicase

Experimental group

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

Treatment:

Drug: RASBURICASE SR29142