Clinical trial · Interventional
Pharmacokinetic Evaluation of Rasburicase in Patients With Leukemia and/or Lymphoma at High Risk of TLS
Pharmacokinetic Evaluation of Rasburicase Dosed for 5 Consecutive Days as Uricolytic Therapy in Adult Patients With Leukemia and/or Lymphoma at High or Potential Risk of Tumor Lysis Syndrome (TLS)
- 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 1\. To determine the pharmacokinetic (PK) parameters of rasburicase in adult patients with leukemia and/or lymphoma at high risk or potential risk of tumor lysis syndrome (TLS) Secondary 1. To evaluate plasma uric acid AUC from baseline (within 4 hours prior to first rasburicase treatment) through 48 hours after the last per-protocol planned administration of rasburicase treatment; 2. To evaluate the safety of rasburicase in adult patients with leukemia and/or lymphoma. 3. To evaluate incidence, duration, and type of immune responses (IgG, IgE, and neutralizing antibody) to rasburicase.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rasburicase | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rasburicase
- interventionNames
- Drug: Rasburicase
Primary outcomes (1)
- measure
- Effectiveness of rasburicase in treatment of patients with leukemia and/or lymphoma who are at high or potential risk for TLS.
- timeFrame
- 4 Years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \>/= 18 2. Risk of TLS: A. High risk: hyperuricemia of malignancy; diagnosis of aggressive lymphoma/leukemia based on Revised European-American Lymphoma (REAL) classification; acute myeloid leukemia in blast crisis; high grade myelodysplastic syndrome only if they have \>10% bone marrow blast involvement and given aggressive treatment similar to AML; OR B. Potential risk: diagnosis of aggressive lymphoma/leukemia based on (REAL) classification. Plus one or more of the following criteria: LDH \>/=2 x 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. Positive tests for HBs antigen, HCV antibodies, or HIV-1, 2 antibodies 7. Hypersensitivity to uricases or any of the excipients 8. Previous therapy with urate oxidase 9. Other conditions unsuitable for participation in the trial in the Investigator's opinion 10. Unwilling to comply with the requirements of the protocol
References
Publications (0)
Data not yet available