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
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 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 August 28, 2014