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

Goethe University

Status and phase: Completed; Phase 3

Conditions: Adult Acute Lymphocytic Leukemia; High-grade Lymphoma

Treatments: Drug: Rasburicase; Drug: Allopurinol

Study type: Interventional

Funder types: Other

Identifiers

NCT00199043

GMALL08

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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™

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Only 1 arm

Experimental group

Treatment:

Drug: Rasburicase

Drug: Allopurinol