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

Phase 3

Completed

• Conditions: Adult Acute Lymphocytic Leukemia; High-grade Lymphoma
• Interventions: Drug: Allopurinol; Drug: Rasburicase

• Registration Number: NCT00199043
• Lead Sponsor: Goethe University

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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™

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Only 1 arm	Allopurinol	-
Only 1 arm	Rasburicase	-

Primary Outcome Measures

Name	Time	Method
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	3 weeks	after cycle 1

Secondary Outcome Measures

Name	Time	Method
response rate, incidence of tumor lysis syndrome	3 weeks	after cycle 1

Trial Locations

Locations (1)

University Hospital, Medical Dept. II; 🇩🇪 Frankfurt, Germany