Hyperuricemia
Conditions
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.
Interventions
DRUGTULY
TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days
Sponsors
Virchow Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy | 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
| Measure | Time frame |
|---|---|
| Plasma uric acid AUC 0-96 hr | 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 |
| Incidence of adverse events | 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 |
Countries
India
Outcome results
None listed