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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virchow Group
ClinicalTrials.gov Identifier:
NCT00921375
First received: May 23, 2009
Last updated: December 11, 2014
Last verified: December 2014
  Purpose
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 Intervention Phase
Hyperuricemia
Drug: TULY
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy and Safety of TULY in Prevention and Treatment of Malignancy-associated Hyperuricemia

Resource links provided by NLM:


Further study details as provided by Virchow Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: February 2010
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   1 Year to 75 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921375

Locations
India
Dr. Raghunathrao
Hyd, Andhra Pradesh, India
Sponsors and Collaborators
Virchow Group
Investigators
Principal Investigator: Dr. Raghunadharao D NIMS
  More Information

Responsible Party: Virchow Group
ClinicalTrials.gov Identifier: NCT00921375     History of Changes
Other Study ID Numbers: VB037/2007  VB037 
Study First Received: May 23, 2009
Last Updated: December 11, 2014
Health Authority: India: Drugs Controller General of India

Additional relevant MeSH terms:
Hyperuricemia
Pathologic Processes
Rasburicase
Gout Suppressants
Antirheumatic Agents

ClinicalTrials.gov processed this record on December 07, 2016