Clinical trial · Interventional
Rasburicase in Patients at Risk for Tumor Lysis Syndrome
Phase 2 Study of Rasburicase Administered by Two Different Schedules (Fixed Dosing vs. As Needed Dosing) in Patients at High Risk or Potential Risk for Tumor Lysis Syndrome
- 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)
Primary Objectives: To determine the efficacy of rasburicase administered as a single dose followed by as needed dosing (investigational arm) as compared to fixed dosing for 5 days (standard treatment arm) in the treatment of patients at high risk or potential risk for tumor lysis syndrome. Secondary Objectives: 1. To evaluate the plasma uric acid area under the curve (AUC) from baseline through 7 days 2. To evaluate the incidence of renal insufficiency and electrolyte abnormalities. 3. To determine the safety and immunogenicity of rasburicase. 4. To evaluate the cost-effectiveness of the experimental treatment (investigational arm).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumor Lysis Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| As Needed Rasburicase | Drug | — | UNRESOLVED |
| Fixed Dose Rasburicase | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- description
- As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
- interventionNames
- Drug: As Needed Rasburicase
- type
- EXPERIMENTAL
- label
- Group B
- description
- Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
- interventionNames
- Drug: Fixed Dose Rasburicase
Primary outcomes (1)
- measure
- Number of Participants With Plasma Uric Acid (UA) Response
- timeFrame
- First cycle of chemotherapy, up to 5 days
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patients with hematological malignancies (leukemia/lymphoma) at high risk or potential risk for tumor lysis syndrome. High risk: hyperuricemia of malignancy (Uric acid levels \>7.5); diagnosis of very aggressive lymphoma/leukemia based on Revised European-American Lymphoma (REAL) classification; acute myeloid leukemia, chronic myelocytic leukemia (CML) in blast crisis; high grade myelodysplastic syndrome only if they have \>10% bone marrow blast involvement and given aggressive treatment similar to acute myeloid leukemia (AML) (continued on #2) 2. (continued from # 1) Potential risk: diagnosis of aggressive lymphoma/leukemia based on (REAL) classification. Plus one or more of the following criteria: lactate dehydrogenase (LDH) \>/= 2 x upper limit of normal (ULN); Stage III-IV disease; Stage I-II disease with at least 1 lymph node/tumor \>5cm in diameter. 3. ECOG performance status 0-3 4. Life expectancy \>3 months 5. Negative pregnancy test (females of child bearing potential) within \</=2 weeks of rasburicase dose and use of efficient contraceptive method (both males and females). Pregnancy test may be performed on serum (HCG) or urine (HCG) 6. Signed written informed consent (approved by the Institutional Review Board/Ethics Committee) obtained prior to study entry Exclusion Criteria: 1. Patient receiving any investigational drug for hyperuricemia within 30 days of planned first treatment with rasburicase 2. Pregnancy or lactation 3. Known history of significant allergy problem or documented history of asthma or asthmatic bronchitis 4. Known history of glucose-6-phosphate dehydrogenase deficiency 5. Known history of hemolysis and methemoglobinemia 6. Previous therapy with urate oxidase 7. Other conditions unsuitable for participation in the trial in the Investigator's opinion 8. Unwillingness to comply with the requirements of the protocol 9. Use of allopurinol within 72 hours of the study entry
References
Publications (1)
- RESULTVadhan-Raj S, Fayad LE, Fanale MA, Pro B, Rodriguez A, Hagemeister FB, Bueso-Ramos CE, Zhou X, McLaughlin PW, Fowler N, Shah J, Orlowski RZ, Samaniego F, Wang M, Cortes JE, Younes A, Kwak LW, Sarlis NJ, Romaguera JE. A randomized trial of a single-dose rasburicase versus five-daily doses in patients at risk for tumor lysis syndrome. Ann Oncol. 2012 Jun;23(6):1640-5. doi: 10.1093/annonc/mdr490. Epub 2011 Oct 19. PMID 22015451