Clinical trial NCT00921375: Safety and Efficacy of TULY (Rasburicase) in Prevention and Treatment of Malignancy-associated Hyperuricemia
Official title: Efficacy and Safety of TULY in Prevention and Treatment of Malignancy-associated Hyperuricemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperuricemia
Lead sponsor: Virchow Group
Sponsor class: INDUSTRY
First posted: 2009-06-16
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is a prospective, open-label, multicentre study. Hundred eligible patients with stage III or IV non-Hodgkin lymphoma (NHL) or acute lymphoblastic leukemia (ALL) with a peripheral white blood cell (WBC) count of \> 25,000/µL or any leukemia or lymphoma with plasma uric acid level of at least 8 mg/dL will be treated with rasburicase 0.20 mg/kg body weight intravenously for 4 days. The primary endpoints viz., the percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy, plasma uric acid AUC 0-96 hr and incidence of adverse events will be assessed during 11 days study period.

Detailed description: All eligible patients will be treated with rasburicase 0.20 mg/kg body weight intravenously for 4 days. The primary endpoints viz., the percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy, plasma uric acid AUC 0-96 hr and incidence of adverse events will be assessed during 11 days study period.

Eligibility criteria: Inclusion Criteria:

1. Patients of both genders aged between 1 to 75 years;
2. Patients with stage III or IV non-Hodgkin lymphoma (NHL) or acute lymphoblastic leukemia (ALL) with a peripheral WBC count of \>25,000/µL or any leukemia or lymphoma with plasma uric acid level of at least 8 mg/dL;
3. Eastern Cooperative Oncology Group (ECOG) performance scale of ≤3;
4. Patients scheduled to receive chemotherapy.

Exclusion Criteria:

1. Patients with allergy or asthma, or hypersensitivity to urate oxidase, or hemolytic reactions;
2. Pregnant and lactating;
3. Patients with glucose-6-phosphate dehydrogenase deficiency;
4. Exposure to rasburicase or allopurinol within 7 days;
5. History of psychiatric or co-morbid unstable medical conditions

Primary outcomes:
measure: Percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy
timeFrame: At the end of 4 hrs after initiation of uric acid lowering therapy; during 96 hrs of uric acid lowering therapy; Adverse events during the entire study period
Secondary outcomes:
measure: Plasma uric acid AUC 0-96 hr
timeFrame: At the end of 4 hrs after initiation of uric acid lowering therapy; during 96 hrs of uric acid lowering therapy; Adverse events during the entire study period
measure: Incidence of adverse events
timeFrame: At the end of 4 hrs after initiation of uric acid lowering therapy; during 96 hrs of uric acid lowering therapy; Adverse events during the entire study period
Other outcomes:
Locations:
city: Hyd
country: India
facility: Dr. Raghunathrao
state: Andhra Pradesh
Study officials:
affiliation: NIMS
name: Dr. Raghunadharao D
role: PRINCIPAL_INVESTIGATOR
References: