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NCT00199043

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)

Completed Phase 3 Last updated 15 March 2023
What this trial tests

Phase 3 trial testing Allopurinol in Adult Acute Lymphocytic Leukemia in 80 participants. Completed in 1 May 2008.

Timeline
1 May 2003
Primary endpoint
1 May 2008
1 May 2008

Quick facts

Lead sponsorGoethe University
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment80
Start date1 May 2003
Primary completion1 May 2008
Estimated completion1 May 2008
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Goethe University

Who can join

15 and older, any sex, with Adult Acute Lymphocytic Leukemia or High-grade Lymphoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Urate oxidase for the prevention and treatment of tumour lysis syndrome in children with cancer.
    Cheuk DK, Chiang AK, Chan GC, Ha SY. · · 2017 · cited 12× · PMID 28272834 · DOI 10.1002/14651858.cd006945.pub4

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Other trials of Allopurinol

Trials testing the same drug.

Other Goethe University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00199043.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing