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

Adult Acute Lymphocytic Leukemia Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199043
• Other study ID #: GMALL08
• Status: Completed
• Phase: Phase 3
• Start date: May 2003
• Est. completion date: May 2008

Study information

• Verified date: March 2023
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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™

Related Conditions & MeSH terms

• Adult Acute Lymphocytic Leukemia
• High-grade Lymphoma
• Hyperuricemia
• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, Non-Hodgkin
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Allopurinol

• Rasburicase

Locations

Country	Name	City	State
Germany	University Hospital, Medical Dept. II	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	after cycle 1	3 weeks
Secondary	response rate, incidence of tumor lysis syndrome	after cycle 1	3 weeks