Prophylactic Use of ELITEK^® (rasburicase) IV Infusion Was Studied in Pediatric Patients

ELITEK was studied in pediatric patients at high risk of tumor lysis syndrome (TLS) associated with hyperuricemia²

Patients meeting at least 1 of the following criteria were enrolled in the trial²:

• Murphy stage III or IV NHL
• ALL with peripheral WBC count of ≥25,000/µL at presentation
• Any childhood lymphoma or leukemia with a uric acid level of ≥8 mg/dL at the time of study

Additional eligibility criteria were life expectancy of ≥4 weeks and an ECOG PS ≤3, or a Karnofsky scale of ≥30%.²

Antihyperuricemic therapy in both arms was initiated prior to anticancer therapy¹

• Phase 3: a randomized, multicenter, open-label, controlled study in pediatric patients (N=52) with leukemia or lymphoma at high risk for TLS associated with hyperuricemia^1,2

• Primary endpoint: reduction in uric acid levels measured from the last value prior to the first dose of study drug until 4 days (96 hours) after that first dose (AUC_{0-96 hr}) of ELITEK vs allpurinol¹

PEDIATRIC CLINICAL TRIAL DESIGN¹*

^*Actual deviations from study protocol occurred in 2/52 patients (antitumor therapy was same as first administration of ELITEK or may have been prior to ELITEK administration).^1,2

The recommended dose of ELITEK is 0.2 mg/kg as a 30-minute lV infusion daily for up to 5 days. Dosing beyond 5 days or administration of more than 1 course is not recommended.¹

ELITEK was studied in majority-pediatric patients at high, intermediate, and low risk of TLS associated with hyperuricemia³

Patients meeting at least 1 of the following criteria were enrolled in the trial³:

• NHL ≥ stage III
• NHL ≥ stage II with high tumor burden defined as LDH level twice or more the ULN and/or tumor mass with a diameter ≥10 cm
• ALL or acute non-lymphoid leukemia
   

Additional eligibility criteria were life expectancy of ≥4 weeks and Karnofsky scale of ≥30% or an ECOG PS ≤3.³

Patients were stratified based on risk levels defined as³:

^†Immediately prior to first dose of study drug.

ELITEK was administered prior to and concurrent with anticancer therapy¹

• A multicenter, single-arm study conducted in 107 patients (89 pediatric, 18 adult) with hematologic malignancies at risk for TLS associated with hyperuricemia^1,3

• Primary endpoint: maintenance of uric acid levels ≤6.5 mg/dL (patients <13 years) or ≤7.5 mg/dL (patients ≥13 years) within 48 hours post-initiation of ELITEK until 24 hours after last administration without the need for allopurinol or other agents¹

PEDIATRIC CLINICAL TRIAL DESIGN^1,3‡

^‡Actual deviations from study protocol occurred in 2/107 patients (antitumor therapy given prior to first administration of ELITEK); presumed deviations from study protocol occurred in 18/107 patients (antitumor therapy was same as first administration of ELITEK or may have been prior to ELITEK administration).³

The recommended dose of ELITEK is 0.2 mg/kg as a 30-minute lV infusion daily for up to 5 days. Dosing beyond 5 days or administration of more than 1 course is not recommended.¹

ELITEK was studied in majority-pediatric patients at high, intermediate, and low risk of TLS associated with hyperuricemia³

Patients meeting at least 1 of the following criteria were enrolled in the trial³:

• Small, noncleaved-cell (Burkitt or non-Burkitt) NHL ≥ stage III
• B-cell leukemia (of Burkitt type) with L₃ morphology by FAB classification
• ALL with WBC count ≥50,000/mm³
• ALL without regard to WBC count, but with clinical, radiological, or laboratory evidence of high tumor burden that, in the opinion of the investigator, would produce significant hyperuricemia during tumor lysis
• Lymphoblastic lymphomas ≥ stage Ill with clinical, radiological, or laboratory evidence of high tumor burden that, in the opinion of the investigator, would produce significant hyperuricemia during tumor lysis
• Lymphoma or leukemia with a uric acid level of ≥8 mg/dL and either creatinine or LDH level at least twice the ULN

Additional eligibility criteria were life expectancy of ≥4 weeks and Karnofsky scale of ≥30% or an ECOG PS ≤3.³

Patients were stratified based on risk levels defined as³:

^†Immediately prior to first dose of study drug.

ELITEK was administered prior to and concurrent with anticancer therapy¹

• A multicenter, single-arm study conducted in 131 patients (130 pediatric, 1 adult) with hematologic malignancies at risk for TLS associated with hyperuricemia^1,3

• Primary endpoint: maintenance of uric acid levels ≤6.5 mg/dL (patients <13 years) or ≤7.5 mg/dL (patients ≥13 years) within 48 hours post-initiation of ELITEK until 24 hours after last administration without the need for allopurinol or other agents¹

PEDIATRIC CLINICAL TRIAL DESIGN^1,3‖

^IIActual deviations from study protocol occurred in 3/131 patients (antitumor therapy given prior to first administration of ELITEK); presumed deviations from study protocol occurred in 13/131 patients (antitumor therapy was same as first administration of ELITEK or may have been prior to ELITEK administration).³

The recommended dose of ELITEK is 0.2 mg/kg as a 30-minute lV infusion daily for up to 5 days. Dosing beyond 5 days or administration of more than 1 course is not recommended.¹