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)
15 Years
N/A
Both
Adult Acute Lymphocytic Leukemia, High-Grade Lymphoma
Trial Information
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)
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™
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Principal Investigator
Dieter Hoelzer, MD,PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospital of Frankfurt, Medical Dept. II
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
GMALL08
NCT ID:
NCT00199043
Start Date:
May 2003
Completion Date:
May 2008
Related Keywords:
- Adult Acute Lymphocytic Leukemia
- High-Grade Lymphoma
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Hyperuricemia
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