Safety and Efficacy of TULY (Rasburicase) in Prevention and Treatment of Malignancy-associated Hyperuricemia

• Sponsor: Virchow Group (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00921375
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Duration (Months): 23
• Patients Per Site Per Month: 4.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperuricemia	Drug: TULY	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Efficacy and Safety of TULY in Prevention and Treatment of Malignancy-associated Hyperuricemia
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tuly, uric acid lowering drug TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days	Drug: TULY; TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Raghunathrao	Hyd	Andhra Pradesh	India

Sponsors and Collaborators

• Virchow Group

Investigators

• Principal Investigator: Dr. Raghunadharao D, NIMS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Virchow Group
• ClinicalTrials.gov Identifier: NCT00921375
• Other Study ID Numbers: VB037/2007; VB037
• First Posted: Jun 16, 2009
• Last Update Posted: Dec 12, 2014
• Last Verified: Dec 1, 2014

• Additional relevant MeSH terms: Hyperuricemia

Study Results

No Results Posted as of Dec 12, 2014