Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Lymphocytic Leukemia | Adult Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| High-grade Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allopurinol | Drug | — | UNRESOLVED |
| Rasburicase | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Only 1 arm
- interventionNames
- Drug: Allopurinol
- Drug: Rasburicase
Primary outcomes (1)
- measure
- 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
- timeFrame
- 3 weeks
- description
- after cycle 1
Secondary outcomes (1)
- measure
- response rate, incidence of tumor lysis syndrome
- timeFrame
- 3 weeks
- description
- after cycle 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
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™
References
Publications (0)
Data not yet available