Last reviewed · How we verify
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)
Phase 3 trial testing Allopurinol in Adult Acute Lymphocytic Leukemia in 80 participants. Completed in 1 May 2008.
1 May 2008
Quick facts
| Lead sponsor | Goethe University |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 May 2003 |
| Primary completion | 1 May 2008 |
| Estimated completion | 1 May 2008 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Allopurinol (ALLOPURINOL) — full drug profile →
- Rasburicase — full drug profile →
Conditions studied
- Adult Acute Lymphocytic Leukemia — all drugs for Adult Acute Lymphocytic Leukemia →
- High-grade Lymphoma — all drugs for High-grade Lymphoma →
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.
-
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
Time frame: 3 weeks
after cycle 1
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):
-
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
Verify or expand the search:
- PubMed search for NCT00199043
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Allopurinol
Trials testing the same drug.
- NCT07089888 — A Study of Dotinurad Versus Allopurinol in Tophaceous Gout · Phase 3 · recruiting
- NCT07089875 — A Study of Dotinurad Versus Allopurinol in Participants With Gout · Phase 3 · recruiting
- NCT05888233 — Allopurinol Improves Heart Function in African Americans With Resistant Hypertension · Phase 2 · recruiting
- NCT06276556 — Extension Study of ABP-671 in Participants With Gout · Phase 2, PHASE3 · terminated
- NCT04875702 — Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout · Phase 4 · recruiting
Other Goethe University trials
Trials by the same sponsor.
- NCT07422844 — Dynamic Network Response to TMS Treatment · recruiting
- NCT07008261 — Robot-assisted Cystectomies With Regard to Blood Loss, Pain and Transfusions. · recruiting
- NCT06879184 — Cohort of the Specialist Network Infectious Diseases · not yet recruiting
- NCT06201936 — EPIDURAL- Evaluation of Preexisting Information Regarding Neuroaxial Procedures for Labour Analgesia · recruiting
- NCT06627140 — Expected and Actual Preterm-Birth and Parental Distress: Impact on Children's Mental Health · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00199043 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Goethe University
- Last refreshed: 15 March 2023
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