Back to resultsSafety and Efficacy of TULY (Rasburicase) in Prevention and Treatment of Malignancy-associated Hyperuricemia
Primary Purpose
Hyperuricemia
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
TULY
Sponsored by
About this trial
This is an interventional prevention trial for Hyperuricemia
Eligibility Criteria
Inclusion Criteria:
- Patients of both genders aged between 1 to 75 years;
- 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;
- Eastern Cooperative Oncology Group (ECOG) performance scale of ≤3;
- Patients scheduled to receive chemotherapy.
Exclusion Criteria:
- Patients with allergy or asthma, or hypersensitivity to urate oxidase, or hemolytic reactions;
- Pregnant and lactating;
- Patients with glucose-6-phosphate dehydrogenase deficiency;
- Exposure to rasburicase or allopurinol within 7 days;
- History of psychiatric or co-morbid unstable medical conditions
Sites / Locations
- Dr. Raghunathrao
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tuly, uric acid lowering drug
Arm Description
TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days
Outcomes
Primary Outcome Measures
Percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy
Secondary Outcome Measures
Plasma uric acid AUC 0-96 hr
Incidence of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00921375
Brief Title
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
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virchow Group
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tuly, uric acid lowering drug
Arm Type
Experimental
Arm Description
TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days
Intervention Type
Drug
Intervention Name(s)
TULY
Intervention Description
TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days
Primary Outcome Measure Information:
Title
Percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy
Time Frame
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 Outcome Measure Information:
Title
Plasma uric acid AUC 0-96 hr
Time Frame
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
Title
Incidence of adverse events
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of both genders aged between 1 to 75 years;
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;
Eastern Cooperative Oncology Group (ECOG) performance scale of ≤3;
Patients scheduled to receive chemotherapy.
Exclusion Criteria:
Patients with allergy or asthma, or hypersensitivity to urate oxidase, or hemolytic reactions;
Pregnant and lactating;
Patients with glucose-6-phosphate dehydrogenase deficiency;
Exposure to rasburicase or allopurinol within 7 days;
History of psychiatric or co-morbid unstable medical conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Raghunadharao D
Organizational Affiliation
NIMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Raghunathrao
City
Hyd
State/Province
Andhra Pradesh
Country
India
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of TULY (Rasburicase) in Prevention and Treatment of Malignancy-associated Hyperuricemia
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