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

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johann Wolfgang Goethe University Hospital
• Treatments: Allopurinol; Rasburicase

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™