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Treatment of Hyperuricemia With Rasburicase in Patients With Acute Lymphoblastic Leukemia or High Grade Lymphoma

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ClinicalTrials.gov Identifier: NCT00199043
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : August 23, 2010
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospital

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.

Condition or disease Intervention/treatment Phase
Adult Acute Lymphocytic Leukemia High-Grade Lymphoma Drug: Allopurinol Drug: Rasburicase Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : May 2003
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008





Primary Outcome Measures :
  1. 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 Measures :
  1. response rate, incidence of tumor lysis syndrome


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients of the GMALL B-ALL/NHL-Study 2002
  • patients of the GMALL-Study 07/2003
  • patients of the GMALL-Study Elderly 1/2003 which fulfill the following criteria:
  • bulky disease (> 7.5 cm)
  • high LDH (> 2 x UNL)
  • uric acid >8 mg/dl/ >475µmol/L at diagnosis
  • leukocytes > 30 000/µl

Exclusion Criteria:

  • exclusion Criteria of the GMALL B-ALL/NHL Study 2002 or the GMALL-Study 07/2003 or GMALL-Elderly 1/2003 and:
  • asthma or severe, live-threatening atopic allergy in history
  • hypersensitivity against Uric acid
  • Glucose-6-Phosphate-Dehydrogenase deficiency
  • pretreatment with Rasburicase or Urikozyme™

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199043


Locations
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Germany
University Hospital, Medical Dept. II
Frankfurt, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
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Study Chair: Dieter Hoelzer, MD,PhD University Hospital of Frankfurt, Medical Dept. II

Additional Information:
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ClinicalTrials.gov Identifier: NCT00199043     History of Changes
Other Study ID Numbers: GMALL08
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: August 23, 2010
Last Verified: May 2008

Additional relevant MeSH terms:
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Lymphoma
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hyperuricemia
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Allopurinol
Rasburicase
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs