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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00664144 |
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Date of registration:
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18/04/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Rasburicase for the Treatment/Prevention of Hyperuricemia in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma
GRAAL2 |
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Scientific title:
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Study of Efficacy and Safety of Rasburicase for the Treatment/Prevention of Hyperuricemia Related to Tumor Lysis Syndrome in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma, Previously Treated or Not With Urate Oxidase Presenting With Hyperuricemia and/or Bulky Disease |
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Date of first enrolment:
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July 2002 |
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Target sample size:
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33 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00664144 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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France
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Germany
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Italy
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Contacts
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Name:
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ICD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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Patients with histologically proven aggressive Non Hodgkin's Lymphoma
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hyperuricemia
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Intervention(s)
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Drug: Rasburicase (SR29142)
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Primary Outcome(s)
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responder rate (based on normalization of uric acid levels)
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Secondary ID(s)
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EFC4983
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L_8433
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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