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OpenTrials
Completed

NCT Number: NCT00921375

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

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.

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Key information

Conditions

Hyperuricemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr. Raghunathrao

Hyd, Andhra Pradesh, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of both genders aged between 1 to 75 years;
  • 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;
  • Eastern Cooperative Oncology Group (ECOG) performance scale of ≤3;
  • Patients scheduled to receive chemotherapy.

Exclusion criteria

  • Patients with allergy or asthma, or hypersensitivity to urate oxidase, or hemolytic reactions;
  • Pregnant and lactating;
  • Patients with glucose-6-phosphate dehydrogenase deficiency;
  • Exposure to rasburicase or allopurinol within 7 days;
  • History of psychiatric or co-morbid unstable medical conditions

Treatment and study plan

TULY

Drug

TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Virchow Group

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jun 16, 2009
Registry last updated
Dec 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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