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

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)

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.

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™