Status:
COMPLETED
Treatment of Hyperuricemia With Rasburicase in Patients With Acute Lymphoblastic Leukemia or High Grade Lymphoma
Lead Sponsor:
Goethe University
Conditions:
Adult Acute Lymphocytic Leukemia
High-grade Lymphoma
Eligibility:
All Genders
15+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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™
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00199043
Start Date
May 1 2003
End Date
May 1 2008
Last Update
March 17 2023
Active Locations (1)
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1
University Hospital, Medical Dept. II
Frankfurt, Germany, 60590