Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies
Stopped early · Phase 2
Conditions studied: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Blastic Phase Chronic Myelogenous Leukemia, Contiguous Stage II Adult Burkitt Lymphoma, de Novo Myelodysplastic Syndromes, Noncontiguous Stage II Adult Burkitt Lymphoma, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Adult Burkitt Lymphoma, Stage I Adult Burkitt Lymphoma, Stage III Adult Burkitt Lymphoma, Stage IV Adult Burkitt Lymphoma, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Adult Acute Myeloid Leukemia
In brief
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.
Key facts
- Study ID
- NCT01564277
- Run by
- Roswell Park Cancer Institute
- People needed
- 24
- Starts
- 2011-09-29
- Expected to finish
- 2016-05-28
- Last updated by the study team
- 2018-01-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Roswell Park Cancer Institute — Buffalo, New York, United States
Full record on ClinicalTrials.gov
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