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Treatment of Hyperuricemia With Rasburicase in Patients With Acute Lymphoblastic Leukemia or High Grade Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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)

NCT00199043•Goethe University

View on ClinicalTrials.gov

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.

Eligibility

Age

15 - No limit years

Sex

ALL

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

•asthma or severe, live-threatening atopic allergy in history
•hypersensitivity against Uric acid
•Glucose-6-Phosphate-Dehydrogenase deficiency
•pretreatment with Rasburicase or Urikozyme™

Locations (1)

University Hospital, Medical Dept. II

Frankfurt, Germany

Key Dates

Start Date

May 1, 2003

Primary Completion Date

May 1, 2008

Completion Date

May 1, 2008

Last Updated

March 17, 2023

Enrollment

ACTUAL participants

Conditions

Adult Acute Lymphocytic LeukemiaHigh-grade Lymphoma

Interventions

Allopurinol

DRUG

Rasburicase

DRUG

German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003)

NCT00198991

Adult Acute Lymphocytic Leukemia

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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