Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Allopurinol; Rasburicase

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