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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Virchow Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Virchow Group
ClinicalTrials.gov Identifier:
NCT00921375
First received: May 23, 2009
Last updated: February 11, 2010
Last verified: June 2009
  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: Allocation: Non-Randomized
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 ]
  • 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 ]

Estimated Enrollment: 100
Study Start Date: June 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: November 2009 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921375

Locations
India
Dr. Raghunathrao Recruiting
Hyd, Andhra Pradesh, India
Contact: Raghunathrao D    91-40-23371747    draghu_hyd@dataone.in   
Sponsors and Collaborators
Virchow Group
Investigators
Principal Investigator: Dr. Raghunadharao D NIMS
  More Information

No publications provided

Responsible Party: Dr. Raghunadharao, Professor & Head of Dept. of Medical Oncology, Nizam's Institute Of Medical Sciences (NIMS)
ClinicalTrials.gov Identifier: NCT00921375     History of Changes
Other Study ID Numbers: VB037/2007, VB037
Study First Received: May 23, 2009
Last Updated: February 11, 2010
Health Authority: India: Drugs Controller General of India

Additional relevant MeSH terms:
Hyperuricemia
Pathologic Processes
Rasburicase
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014