Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
After signing the informed consent and having met the inclusion criteria, patients will be randomized to 1 of the 3 arms and treated for a total duration of 5 days. Patients in all arms will receive chemotherapy beginning 4-24 hours after the first dose of rasburicase or allopurinol.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 consent
Clareo Health | Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome