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

Phase 3

Completed

• Conditions: Hyperuricemia
• Interventions: Drug: TULY

• Registration Number: NCT00921375
• Lead Sponsor: Virchow Group

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.

Study Timeline

• Study First Submitted: 2009-05-23
• Study First Submitted QC: 2009-06-14
• Study First Posted: 2009-06-16
• Study Start: 2010-02
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-11
• Last Update Posted: 2014-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tuly, uric acid lowering drug	TULY	TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Dr. Raghunathrao; 🇮🇳 Hyd, Andhra Pradesh, India

Dr. Raghunathrao

🇮🇳Hyd, Andhra Pradesh, India