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

NCT ID: NCT00921375

Last Updated: 2014-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-01-31

Brief Summary

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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

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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.

Conditions

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Hyperuricemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Tuly, uric acid lowering drug

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

Group Type EXPERIMENTAL

TULY

Intervention Type DRUG

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

Interventions

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TULY

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virchow Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Raghunadharao D

Role: PRINCIPAL_INVESTIGATOR

NIMS

Locations

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Dr. Raghunathrao

Hyd, Andhra Pradesh, India

Site Status

Countries

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India

Other Identifiers

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VB037

Identifier Type: OTHER

Identifier Source: secondary_id

VB037/2007

Identifier Type: -

Identifier Source: org_study_id