Clinical trial · Interventional
Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
Evaluation of Single Agent Rasburicase for 5 Days Versus Sequential Treatment With Rasburicase From Day 1 Through 3 Followed by Oral Allopurinol From Day 3 Through 5 (Overlap on Day 3) Versus Single Agent Oral Allopurinol for 5 Days in the Management of Plasma Uric Acid in Adult Patients With Leukemia, Lymphoma, and Solid Tumor Malignancies at Risk for Hyperuricemia and 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)
This is a randomized, multi-center, open-label, parallel group study with three arms: * Rasburicase alone * Rasburicase followed by Allopurinol * Allopurinol alone The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Hyperuricemia | — | UNRESOLVED | — |
| Tumor Lysis Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allopurinol | Drug | — | UNRESOLVED |
| Rasburicase (SR29142) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Rasburicase alone given as a single agent for 5 days
- interventionNames
- Drug: Rasburicase (SR29142)
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Rasburicase alone given as a single agent from Day 1 through Day 3, followed by oral allopurinol given from Day 3 through Day 5 (Day 3 is an overlap)
- interventionNames
- Drug: Rasburicase (SR29142)
- Drug: Allopurinol
- type
- ACTIVE_COMPARATOR
- label
- Arm C
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
1. Meets high risk or at potential risk for tumor lysis syndrome (TLS):
A patient is at high risk for TLS if he/she presents with:
* Hyperuricemia of malignancy (plasma uric acid \> 7.5 mg/dL);
* A diagnosis of very aggressive lymphoma/leukemia based on the Revised European-American Lymphoma (REAL) classification of lymphoma/leukemia;
* Acute myeloid leukemia (AML);
* Chronic myeloid leukemia (CML) in blast crisis; or
* High grade myelodysplastic syndrome (refractory anemia with excess blast, chronic myelomonocytic leukemia, and refractory anemia with excess blast in transformation) only if they have \> 10% bone marrow blast involvement and are given aggressive treatment similar to AML.
A patient is at potential risk for TLS if he/she presents with:
* A diagnosis of aggressive lymphoma/leukemia based on the REAL classification of lymphoma/leukemia plus 1 or more of the following criteria:
* Lactate dehydrogenase (LDH) \>= 2 x upper limit of normal (ULN) (IU/L)
* Stage III-IV disease
* Stage I-II disease with at least 1 lymph node/tumor \> 5 cm in diameter
In addition to the above-mentioned eligibility criteria, the patients should have the following criteria:
2. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
3. Age \>= 18 years
4. Life expectancy \> 3 months
5. Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (for both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG).
6. Signed written informed consentReferences
Publications (0)
Data not yet available