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| Descriptive Information Fields | |||||||||
| Brief Title † | Treatment of Hyperuricemia With Rasburicase in Patients With Acute Lymphoblastic Leukemia or High Grade Lymphoma | ||||||||
| Official Title † | Randomised Phase III Trial of Effectivity and Safety of Rasburicase Compared With Allopurinol for Treatment of Hyperuricemia in Patients With Acute Lymphoblastic Leukemia or High-Grade NHL With High Risk of Tumorlysis Syndrome (> 15 Yrs) | ||||||||
| Brief Summary | In this study the efficacy and tolerability of two approaches to treat and prevent hyperuricemia is tested in patients with acute lymphoblastic leukemia or high-grade lymphoma with high risk of tumor lysis syndrome. Both arms are compared by randomisation. In one arm patients receive during pre-phase chemotherapy conventional prophylaxis with allopurinol whereas in the other arm Rasburicase is used. |
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| Detailed Description | |||||||||
| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | renal function, uric acid, electrolytes, adverse events and mortality in pre-phase and the two following cycles of chemotherapy, time and dose compliance of chemotherapy | ||||||||
| Secondary Outcome Measure † | response rate, incidence of tumor lysis syndrome | ||||||||
| Condition † | Adult Acute Lymphocytic Leukemia High-Grade Lymphoma |
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| Intervention † | Drug: Allopurinol Drug: Rasburicase |
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| MEDLINE PMIDs | |||||||||
| Links | European Leukemia Trial Registry  German Leukemia Trial Registry |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 80 | ||||||||
| Start Date † | May 2003 | ||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 15 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Germany | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00199043 | ||||||||
| Organization ID | GMALL08 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Johann Wolfgang Goethe University Hospitals | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Johann Wolfgang Goethe University Hospitals | ||||||||
| Verification Date | May 2008 | ||||||||
| First Received Date † | September 12, 2005 | ||||||||
| Last Updated Date | May 16, 2008 | ||||||||
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