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

Phase 1

• Conditions: Hyperuricemia; MedDRA version: 20.1Level: LLTClassification code 10020907Term: HyperuricemiaSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-003176-14-Outside-EU/EEA
• Lead Sponsor: Sanofi-Aventis Groupe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-29
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- The 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) = 3 on the Eastern Cooperative Oncology Group (ECOG) scale, or a PS = 30 on the Lansky score as per the Investigator’s preference.
- Newly diagnosed NHL or AL who is at the initiation of or during the first cycle of chemotherapy, baseline blood uric acid >8 mg/dL (473 µmol/L) at screening.
- If newly diagnosed NHL patient with blood uric acid = 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 (Tumor lysis syndrome).
- If newly diagnosed AL patient is with blood uric acid = 8 mg/dL at the screening but with a high risk of TLS.
- The patient will receive the chemotherapy, and will be confined in hospital for at least 14 days after first dose of rasburicase.
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.
- 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.
- Male participant with a female partner of childbearing potential not protected by highly-effective method(s) of birth control.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified