Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
Condition: Tumor Lysis Syndrome; Cancer; Hyperuricemia
MeSH terms: Tumor Lysis Syndrome; Syndrome; Hyperuricemia
Intervention: Rasburicase (SR29142); Allopurinol
Intervention description: 30-min IV infusion; Oral administration
Intervention MeSH terms: Allopurinol; Rasburicase
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 280.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hyperuricemia; Tumor lysis syndrome; Leukemia; Lymphoma; Myelodysplastic Syndromes; Solid tumor cancers; Solid Tumor cancers with hyperuricemia Hyperuricemia (cancer patients only); Tumor lysis syndrome (cancer patients only)

Summary:

      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.
    

Eligibility criteria:

        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 consent