Clinical trial · Interventional
Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies
Efficacy and Safety of Two Comparable Single Low Doses of Rasburicase Followed by Allopurinol in Adult Patients With Malignancy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
This randomized phase II trial studies how well giving rasburicase together with allopurinol works in treating patients with hematologic malignancies. Rasburicase may reduce the level of uric acid in the blood. Allopurinol may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known which dose of rasburicase is more effective in treating hematologic malignancies when given together with or without allopurinol.
Conditions
Conditions (19)
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 Myeloid Leukemia With 11q23 (MLL) Abnormalities | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With Del(5q) | Acute Myeloid Leukemia with del(5q) | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) | Adult Acute Myeloid Leukemia with t(16;16)(p13.1;q22); CBFB-MYH11 | ALIAS | 0.90 |
| Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) | Acute Myeloid Leukemia with t(8;21)(q22;q22.1); RUNX1-RUNX1T1 | ALIAS | 0.85 |
| Blastic Phase Chronic Myelogenous Leukemia |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allopurinol | Drug | — | UNRESOLVED |
| rasburicase | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (1.5mg rasburicase)
- description
- Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
- interventionNames
- Drug: rasburicase
- Drug: allopurinol
- type
- EXPERIMENTAL
- label
- Arm II (3 mg rasburicase)
- description
- Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
- interventionNames
- Drug: rasburicase
- Drug: allopurinol
Primary outcomes (1)
- measure
- Probability of Obtaining a Uric Acid Level =< 7.5mg/dL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) status of 0-3 * Active leukemia and Burkitt leukemia/lymphoma treated in-house that puts them at risk for tumor lysis syndrome (TLS) * Serum uric acid level \>= 7.5mg/dL and high risk for TLS as defined by: * A diagnosis of acute myeloid leukemia (AML), or * A diagnosis of blast-phase chronic myeloid leukemia (CML), or * A diagnosis of high-grade myelodysplastic syndrome (MDS) with \>= 10% blast bone marrow blast involvement, or * Acute lymphoblastic leukemia (ALL), or * Burkitt leukemia/lymphoma * Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * History of asthma * History of severe or life threatening atopic allergy * Hypersensitivity to uricases * Known prior sensitivity to allopurinol * Known glucose-6-phosphate dehydrogenase (G6PD) deficiency * Recent prior history of uricolytic therapy defined as therapy within the last 7 days
References
Publications (0)
Data not yet available